Tissue localization device and method of use thereof

ABSTRACT

Tissue localization devices and methods of localizing tissue using tissue localization devices are disclosed. The tissue localization device can comprise a handle comprising a delivery control, a delivery needle extending out from the handle, and a localization element within the delivery needle. The localization element can be deployed out of the delivery needle or retracted back into the delivery needle when the delivery control is translated in a first direction or a second direction, respectively. The localization element can be coupled to a flexible tracking wire.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 62/322,729, filed Apr. 14, 2016, and U.S. ProvisionalPatent Application No. 62/448,307, filed Jan. 19, 2017, which areincorporated herein by reference in their entireties.

FIELD OF TECHNOLOGY

The present disclosure relates generally to the field of tissuelocalization and, more specifically, to a tissue localizing device formarking or bounding a suspect tissue mass.

BACKGROUND

Despite the advances made in technologies such as medical imaging toassist the physician in the diagnosis and treatment of patients withpossible abnormal tissue growth such as cancer, it is still oftennecessary to physically identify abnormal tissue regions for subsequentsurgical removal. One disease for which this approach is a critical toolis breast cancer.

In the detection and treatment of breast cancer, open or excisionalbiopsies are often advisable when a suspicious tissue mass may need tobe removed. In addition, lumpectomy or partial mastectomy may beperformed when the tissue mass is cancerous as part of breastconservation therapy (BCT). One technique that is frequently employed tophysically identify the abnormal tissue region to be removed is calledwire localization. Wire localizations often require a radiologist tomanually insert a wire that contains one or more hooks on its distal endinto the breast of the patient through a needle and then position thehook region of the wire so that the end of the wire resides within or isadjacent to the suspect tissue requiring surgical removal. The needle isremoved and the wire is left in the tissue and the patient is thentransferred to the operating room, typically several hours later, tohave the suspect or target tissue or lesion removed by a surgeon.

However, such wires are often inaccurately placed, and once placed theyare prone to migration, and cannot be easily adjusted once they haveexited the needle. Moreover, even if the wire has been properly placed,the surgeon often cannot intraoperatively identify the tip of the wire,which can result in the surgeon removing a larger portion of tissue thanis necessary to optimize the chances for cancer-free margins of thetissue specimen that is removed. Also, if the suspect tissue mass is notfound at the end of the wire, the surgeon often ends up cutting orremoving non-afflicted tissue without removing the lesion. In addition,after placement but before the surgical procedure, the wire protrudesstiffly from the body and can become dislodged or migrate to positionremote from the originally demarcated region of identified tissue. Whilethe localization wire resides in the patient awaiting surgery, the wirecan be uncomfortable and cannot be adequately secured in a manner thatwould permit the patient to sleep overnight without discomfort orwithout a high risk of dislodgement. Because of these risks associatedwith migration and patient discomfort, the patient must proceed with thesurgical removal of the lesion the same day as the placement of thelocalization wire. In addition, logistical delays between placement ofthe wire and eventual surgical excision can exceed several hours,leading to additional discomfort and risk of migration.

Another drawback of current localization wires is the need to pass theneedle and wire through the lesion leading to potential transmission ofcancer cells, sometimes referred to as needle tract seeding.

Therefore, a solution is needed that can accurately and removably placea localization or marking device into a patient to demarcate a region oftissue for subsequent surgical removal. Such a solution should reliablydefine the border of the tissue to be removed and reduce the risk ofinadvertent migration, even over a period of hours or days.

SUMMARY

Tissue localization devices and methods of localizing tissue usingtissue localization devices are disclosed. The tissue localizationdevice can include a delivery needle having a needle lumen, alocalization element slidably translatable within the needle lumen, anda liner in the needle lumen. The localization element can be detachablefrom the delivery needle. The liner can be slidably translatablerelative to the needle lumen and can be located radially between theneedle lumen and at least part of the localization element.

The localization element can have an echogenic surface treatment. Theechogenic surface treatment can be a surface roughness, a pattern cutinto a surface of the localization element, or combinations thereof.

The tissue localization device can include a handle with a slidabledelivery control and a pusher element partially within the needle lumen.The delivery needle can extend from the handle.

The localization element can be detachably held by the pusher element.The localization element can be detachable from the pusher element inresponse to a translation of the slidable delivery control in a firstlongitudinal direction. The localization element can be releasable fromthe liner when a distal end of the pusher element is translatedlongitudinally beyond the liner.

The slidable delivery control can have a first interface surface and asecond interface surface. The handle can have a proximal end and adistal end. The first interface surface can be upwardly concave whenviewed from the proximal end to the distal end and the second interfacesurface can be upwardly concave when viewed from the distal end to theproximal end.

The handle can have a handle dorsal side and a handle ventral sideopposite the handle dorsal side. The localization element can beconfigured to curve in a direction of the handle dorsal side whendeployed. The handle can have an elongate slot along the handle dorsalside. The slidable delivery control can be coupled to the pusher elementvia a fastener extending through the elongate slot.

The pusher element can have or be defined by a delivery port at a distalend of the pusher element. At least part of the localization element canbe detachably held within the delivery port when the localizationelement is within the needle lumen. The pusher element can have a pusherdorsal side, a pusher ventral side, and a pusher distal end. The pusherdistal end can be sloped and form an obtuse angle with the pusherventral side.

The tissue localization device can include a spring coupled to aproximal end of the liner. The spring can be configured to be at leastpartially compressed when the pusher element is translated toward adistal end of the delivery needle relative to the liner in response to atranslation of the slidable delivery control in the first longitudinaldirection. The tissue localization device can also have a tracking wirecoupled to the localization element. At least a segment of the trackingwire can be configured to be coiled or tied into a loop.

Furthermore, the tissue localization device can include a deliveryneedle having a needle lumen, a pusher element slidably translatablewithin the needle lumen, and a localization element having aninterlocking framework or interlocking portion. The pusher element canhave or be defined by a delivery port. The interlocking framework can beinterlockable with the delivery port when at least part of the pusherelement resides within the needle lumen. The interlocking framework canbe releasable from the delivery port when the delivery port exits theneedle lumen.

The interlocking framework of the localization element can include aneyelet frame and a shoulder portion. The eyelet frame can be detachablypositioned within the delivery port when the localization element iswithin the needle lumen.

Furthermore, the tissue localization device can include a handle with aslidable delivery control and a delivery needle extending out from thehandle. The delivery needle can have a needle lumen and a pusher elementslidably translatable and partially within the needle lumen. The tissuelocalization device can also include a localization element detachablyheld by the pusher element when in the needle lumen.

The pusher element can have a pusher dorsal side and a pusher ventralside. The needle lumen can have a lumen dorsal surface defining an upperportion or top half of the needle lumen and a lumen ventral surfacedefining a lower portion or bottom half of the needle lumen. The pusherelement can also have a pusher proximal end and a pusher distal endopposite the pusher proximal end. The pusher distal end can be slopedand form an obtuse angle with the pusher ventral side. The obtuse angleformed by the pusher distal end and the pusher ventral side can be seenwhen viewed from a lateral side of the tissue localization device. Thepusher distal end can also form an acute angle with the pusher dorsalside when viewed from the lateral side of the tissue localizationdevice.

At least part of the localization element can be configured to exit thedelivery needle in response to a translation of the slidable deliverycontrol in a first longitudinal direction. The localization element canbe configured to retract into the delivery needle in response to atranslation of the slidable delivery control in a second longitudinaldirection opposite the first longitudinal direction. The localizationelement can be retracted back into the delivery needle after at least apart of the localization element is deployed out of the delivery needle.

The localization element can be constrained into a first configurationwhen within the needle lumen. The localization element can transforminto a second configuration when deployed out of the delivery needle.The second configuration can be a circular shape. The secondconfiguration can also be a half-circle shape, a crescent shape, afalciform shape, or a sickle-shape. The localization element can have anelement distal end with one sharpened element tip. The localizationelement can also have at least two sharpened element tips. The twosharpened element tips can branch out or diverge at an angle away fromone another. The two sharpened element tips can also furcate or branchout. The localization element can have an echogenic surface treatment.The echogenic surface treatment can be a surface roughness, a patterncut into a surface of the localization element, or combinations thereof.

The localization element can have a curvature plane. The entirelocalization element can be substantially within the curvature plane. Inother variations, at least part of the localization element can becurved in alignment with the curvature plane and another part of thelocalization element can curve out of the curvature plane. Thelocalization element can curve into a complete or partial helix.

The tissue localization device can also have a liner partially encasingthe pusher element. The liner can be positioned in between a portion ofthe pusher element and the needle lumen. A portion of the localizationelement can be encased by the pusher element and the liner. The linercan be made from a metallic material a polymer such as a polyether etherketone (PEEK), or combinations thereof. The liner can be a hollow tube.In other variations, the liner can have a dorsal liner and a ventralliner. The dorsal liner can be positioned in between the pusher dorsalside and the lumen dorsal surface. The ventral liner casing can bepositioned in between the pusher ventral side and the lumen ventralsurface.

The tissue localization device can include a spring coupled to aproximal end of the liner. The spring can be configured to be at leastpartially compressed when the pusher element is translated toward adistal end of the delivery needle relative to the liner in response to atranslation of the slidable delivery control in the first longitudinaldirection.

The tissue localization device can also include a tracking wire coupledto the localization element. The tracking wire can be a stainless steelwire covered by a polymer jacketing. The tracking wire can be a flexiblewire capable of being coiled or tied into a loop. At least part of thetracking wire can be covered by a polymer jacketing.

The delivery needle can have a needle dorsal side and a needle ventralside opposite the needle dorsal side. The delivery needle can also havea beveled distal end. The localization element can be configured to exitor be deployed out of the beveled distal end. The beveled distal end canhave a rounded edge along a proximal rim of the beveled distal end at aregion that can be referred to as a heel. The beveled distal end canalso have two lateral sharpened edges converging and meeting at a needletip. The two lateral sharpened edges can be contiguous with or extendout from the rounded edge.

The delivery needle can have a needle dimple proximal to the roundededge along the needle dorsal side. The needle dimple can have a dimplelength and a dimple width. The needle dimple can be a substantiallyoval-shaped dimple. The needle dimple can be a concavity extendingradially into the needle lumen and obstructing part of the needle lumenalong the dimple length.

The pusher element can have a delivery port and the localization elementcan be detachably held within the delivery port. The delivery port canbe a cutout along the pusher dorsal side. The localization element canbe deployed out of the delivery needle when the pusher element pushesthe localization element in the first longitudinal direction. Thelocalization element can be configured to automatically detach ordislodge from the pusher element and the delivery needle when at leastpart of the delivery port is translated by the delivery control out ofthe delivery needle. The localization element can be retracted back intothe delivery needle when at least a portion of the localization elementis still within the delivery port and the pusher element pulls thelocalization element in the second longitudinal direction.

The delivery port can have a distal port side, a proximal port side, anda port base. The distal port side can form an acute angle with the portbase when viewed from the lateral side of the tissue localizationdevice.

The localization element can include a locator proximal end and alocator distal end opposite the locator proximal end. The locator distalend can include a sharpened locator tip. The locator proximal end caninclude an eyelet frame surrounding an aperture, a narrow portion, and ashoulder portion. The eyelet frame can be detachably positioned withinthe delivery port of the pusher element when the movement or translationof the localization element is controlled by the delivery control. Thelocalization element can be deployed out of the delivery needle when thepusher element pushes the shoulder portion of the localization elementin the first longitudinal direction. The localization element can beretracted back into the delivery needle when at least a portion of theeyelet frame is still within the delivery port and the pusher elementpulls on a side of the eyelet frame, namely an eyelet shoulder, in thesecond longitudinal direction.

The localization element can be covered by a blue-oxide finish. Theblue-oxide finish can reduce friction when the localization element istranslated through the needle lumen and makes contact with an innersurface of the needle lumen.

The handle can have a handle distal end, a handle proximal end oppositethe handle distal end, a handle dorsal side, a handle ventral sideopposite the handle dorsal side, and an elongate slot defined along thehandle dorsal side. The handle can also have a handle lumen. At leastpart of the pusher element can slidably translate within the handlelumen. The delivery control can be coupled to the pusher element viafasteners extending through the elongate slot. In some variations, thetissue localization device can comprise a gear mechanism and thetranslation of the pusher element can be facilitated by the gearmechanism.

The delivery control can include a first interface surface and a secondinterface surface. The first interface surface can be upwardly concavewhen viewed from the proximal end to the distal end and the secondinterface surface can be upwardly concave when viewed from the distalend to the proximal end. The localization element can be translated inthe first longitudinal direction when the first interface surface ispushed in the first longitudinal direction. The localization element cancurve in a direction of the handle dorsal side when deployed out of thedelivery needle.

The tracking wire can be coupled to the localization element at variouspoints along the length of the localization element. The tracking wirecan be coupled to the locator proximal end of the localization element.The tracking wire can be coupled or tied to the eyelet frame of thelocalization element. The tracking wire can be threaded through theaperture and tied to the eyelet frame. At least part of the trackingwire can be positioned within the delivery port when the eyelet frame ispositioned within the delivery port. The tracking wire can be coupled tothe localization element at a midpoint along the length of thelocalization element.

The tracking wire can have a wire distal segment and a wire proximalsegment opposite the wire distal segment. At least part of the wiredistal segment can be secured to part of another segment of the wire inbetween the wire distal segment and the wire proximal segment at anattachment site along the wire. The wire distal segment can be securedto part of another segment of the wire by adhesive or spot welding. Forexample, the attachment site can be a weld site. The segment of the wirein between the wire distal segment and the attachment site can be formedas a loop. A polymer jacketing can cover or ensheath at least part ofthe tracking wire. The polymer jacketing can also cover or ensheath theattachment site. The tracking wire can comprise or be composed ofstainless steel. The polymer jacketing can be a heat-shrink polymer ortube wrapped around the tracking wire.

A method for using a tissue localization device is also disclosed. Themethod can involve translating a localization element of the tissuelocalization device in a first longitudinal direction through a needlelumen of a delivery needle of the tissue localization device. The methodcan also involve deploying a localization element of the tissuelocalization device out of the delivery needle into tissue andretracting the localization element into the needle lumen after at leastpart of the localization element is deployed out of the delivery needle.The method can further involve repositioning the tip of the deliveryneedle and redeploying the localization element out of the deliveryneedle into the tissue.

The method can also include deploying the localization element out ofthe delivery needle into a curved configuration having a first curvatureplane and redeploying the localization element out of the deliveryneedle into the curved configuration having a second curvature plane.The method can further involve compressing a spring coupled to aproximal end of a liner partially encasing a pusher element coupled tothe slidable delivery control prior to deploying the localizationelement out of the delivery needle.

The method can also involve advancing a needle tip of the deliveryneedle into the tissue to an offset from a target tissue site of thetissue and positioning an ultrasound transducer on the tissue. Themethod can further involve deploying the localization element out of thedelivery needle by pushing a slidable delivery control of the tissuelocalization device in the first longitudinal direction along a handleof the tissue localization device and moving the ultrasound transduceron the tissue while translating the localization element.

A method of localizing tissue using a tissue localization device is alsodisclosed. The method can involve positioning a delivery needle of thetissue localization device adjacent to or at a target tissue site andholding the handle of the tissue localization device using one hand of auser. The needle tip can be positioned at an offset location adjacent toa target tissue site. The offset location can be separated from thetarget tissue site by less than a difference between a diameter of thelocalization element and a diameter of the target tissue site.

The user can include a surgeon, a radiologist, or another healthprofessional. The method can also involve pushing a slidable deliverycontrol of the tissue localization device in a first longitudinaldirection using at least one finger of the same hand of the user. Themethod can involve translating a localization element of the tissuelocalization device in the first longitudinal direction through a needlelumen of the delivery needle in response to the pushing of the slidabledelivery control.

The method can also involve deploying the localization element out ofthe delivery needle adjacent to or at the target tissue site. At leastpart of the localization element can curve when deployed. The method canalso involve at least partially compressing a spring coupled to aproximal end of a liner partially encasing the pusher element prior todeploying the localization element out of the delivery needle.

The method can further involve retracting the localization element backinto the delivery needle after at least part of the localization elementis deployed out of the delivery needle. Retracting the localizationelement can involve holding the handle of the tissue localization deviceusing the one hand of the user and pulling the slidable delivery controlin a second longitudinal direction using at least one finger of the samehand of the user. The second longitudinal direction can be opposite thefirst longitudinal direction.

The method can further involve deploying the localization element out ofthe delivery needle into a curved configuration having a curvatureplane. The localization element can radially surround at least a portionof a suspect tissue mass in the tissue of the patient such that thecurvature plane of the localization element intersects at least aportion of the suspect tissue mass. In another variation, thelocalization element can be deployed adjacent or proximal to the suspecttissue mass such that the curvature plane does not intersect any portionof the suspect tissue mass.

The localization element can be coupled to a flexible tracking wire. Atleast a segment of the tracking wire can extend out of the tissue of thepatient while a distal end of the tracking wire can be coupled to thelocalization element deployed within the tissue of the patient. Thedistal end of the tracking wire can swivel or rotate relative to thelocalization element when the localization element and the tracking wireare deployed out of the delivery needle and the pusher element. Thedistal end of the tracking wire can swivel or rotate into a deployedalignment. The deployed alignment can be a spatial positioning oralignment which is secant or non-tangent with respect to a curve formedby the deployed localization element. For example, the localizationelement can be deployed into a circular configuration and the distal endof the tracking wire can be aligned secant or non-tangent to thecircular configuration.

The method can further involve retracting a distal tip of the deliveryneedle away from the target tissue site. Retracting the distal tip ofthe delivery needle can expose the tracking wire coupled to thelocalization element.

The method can further involve viewing a position of the localizationelement in tissue using an ultrasound transducer. The method can alsoinvolve moving the ultrasound transducer on a tissue surface proximal tothe target tissue site while deploying the localization element.

The method can involve locating a suspect tissue mass in the patient byperiodically pulling on the segment of a tracking wire extending outsidethe body of the patient. The method can further involve palpating orfeeling, with at least one finger of a user, an outer tissue layer(e.g., a dermis) above the target tissue site while pulling on thesegment of the tracking wire extending outside the body of the patient.The method can further involve locating a suspect tissue mass within thetissue of the patient based on a tension exhibited by the tracking wirebeing pulled and a movement felt by the at least one finger of the user.

The method can further involve coiling the segment of the tracking wireextending out of the tissue of the patient tracking wire into a loop andadhering (e.g., with Tegaderm™ or other biocompatible adhesives ordressings) or otherwise securing the tracking wire extending outside thebody of the patient to the dermis or patient dressing of the patient.

In another variation, a tissue localization device can include a handlehaving a rotatable delivery control, a delivery needle extending outfrom the handle, and a localization element configured to be deployedout of the delivery needle when the delivery control is rotated in afirst rotational direction. The localization element can be in a firstconfiguration when within the delivery needle. The localization elementcan transform into a second configuration when deployed out of thedelivery needle. A part of the localization element can be detachablyheld by a distal end of a pusher element configured to longitudinallytranslate within the delivery needle. The tissue localization device canfurther include a tracking wire coupled to the localization element.

The localization element can be retracted into the delivery needle whenthe rotatable delivery control is rotated in a second rotationaldirection. The rotatable delivery control can include a knob.

The handle can include an orientation arch defined along a handle dorsalside. The orientation arch can have a curvature and the localizationelement can be configured to curve in a direction matching the curvatureof the orientation arch when deployed. The handle can have a handlelumen. The tissue localization device can include a drive pipe withinthe handle lumen. The drive pipe can be configured to rotate within thehandle lumen in response to a rotation of the rotatable deliverycontrol. The drive pipe can have a pipe lumen surrounding a car element.

The car element can be coupled to the pusher element. The car elementcan be configured to translate longitudinally within the pipe lumen ofthe drive pipe in response to the rotation of the drive pipe.

The tissue localization device can further include a sound-generatingelement. The sound-generating element can be configured to produce soundwhen at least part of the localization element exits or is deployed outof the delivery needle. The sound-generating element can include aspring.

The tissue localization device can also include a tactilefeedback-generating element. The tactile feedback-generating element canbe configured to produce tactile feedback at least part of the time whenthe localization element exits or is being deployed out of the deliveryneedle.

In another variation, a method of localizing tissue using a tissuelocalization device involves positioning a delivery needle of the tissuelocalization device adjacent to or at a target tissue site. The methodcan also involve rotating a rotatable delivery control of the tissuelocalization device in a first rotational direction and translating alocalization element of the tissue localization device in a firstlongitudinal direction through a needle lumen of the delivery needle inresponse to the rotation of the rotatable delivery control. Translatingthe localization element in the first longitudinal direction furtherinvolves translating a pusher element within a drive pipe of the tissuelocalization device.

The method can further involve deploying the localization element out ofthe delivery needle adjacent to or at the target tissue site in responseto the rotation of the rotatable delivery control. The method can alsoinvolve retracting a distal tip of the delivery needle away from thetarget tissue site and exposing a tracking wire coupled to thelocalization element while retracting the distal tip of the deliveryneedle.

The method can further involve holding a handle of the tissuelocalization device using one hand of a user and rotating the rotatabledelivery control in the first rotational direction using at least onefinger of the same hand of the user.

The method can also involve retracting the localization element into thedelivery needle after at least part of the localization element isdeployed out of the delivery needle. The localization element can beretracted by holding a handle of the tissue localization device usingone hand of a user and rotating the rotatable delivery control in asecond rotational direction using at least one finger of the same handof the user.

The method can further involve creating tactile feedback using a tactilefeedback-generating element of the tissue localization device when thelocalization element is partially deployed out of a distal tip of thedelivery needle. The method can also involve generating a sound using asound-generating element of the tissue localization device when thelocalization element is partially deployed out of a distal tip of thedelivery needle.

In another variation, a method for localizing tissue using a tissuelocalization device including a delivery needle comprises advancing,using one hand, a needle tip of the delivery needle of the tissuelocalization device into a tissue at an offset from a target tissue siteof the tissue. The method can further involve positioning, using anotherhand, an ultrasound transducer proximal to the target tissue site on atissue surface of the tissue. The method can also involve deploying alocalization element out of the delivery needle into the tissue. Themethod can further involve moving the ultrasound transducer on thetissue surface while deploying the localization element.

A tissue localization system is also disclosed. The tissue localizationsystem can include a tissue localization device configured to be held byonly one hand of a user and an ultrasound transducer configured to beheld by only one hand of a user and moved on a surface of the tissuewhile the localization element is deployed into the tissue. The tissuelocalization device can include a handle with a slidable deliverycontrol, a delivery needle extending from the handle, and a pusherelement coupled to the slidable delivery control. The tissuelocalization device of the tissue localization system can also include alocalization element detachably held by the pusher element. The pusherelement can be configured to deploy at least part of the localizationelement from the delivery needle into a tissue in response to atranslation of the slidable delivery control.

A tracking wire to locate a marked target tissue site is also disclosed.The tracking wire can include a wire having a wire distal segment and awire proximal segment opposite the wire distal segment. At least part ofthe wire distal segment can be secured to a part of another segment ofthe wire in between the wire distal segment and the wire proximalsegment at an attachment site along the wire. The segment of the wire inbetween the wire distal segment and the attachment site can be formed asa loop. The tracking wire can also include a polymer jacketing coveringat least part of the wire. The attachment site can be covered by thepolymer jacketing.

The wire can be made of stainless steel. At least a segment of thetracking wire can be configured to be deployed into the tissue of apatient. At least a segment of the tracking wire in between the wiredistal segment and the wire proximal segment can be configured to betied into a knot around a portion of a localization element.

A method of preparing a tissue localization assembly is also disclosed.The method can involve threading a wire distal segment of a wire throughan aperture of a localization element. The method can also involvesecuring at least part of the wire distal segment to part of anothersegment of the wire in between the wire distal segment and the wireproximal segment at an attachment site along the wire. The segment ofthe wire in between the wire distal segment and the attachment site canform a loop. The method can further involve covering at least part ofthe wire with a polymer jacketing.

The method can also involve covering the attachment site with thepolymer jacketing. The method can further involve inserting a segment ofthe wire into a lumen of a pusher element of a tissue localizationdevice. The method can also involve positioning at least a part of thelocalization element coupled to the wire into a delivery port of thepusher element. The method can further involve slidably translating thepusher element into a lumen of a delivery needle of the tissuelocalization device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a perspective view of a tissue localization device.

FIG. 1B illustrates a side view of the tissue localization device.

FIG. 1C is a black-and-white image of the tissue localization device.

FIG. 2A illustrates deployment of a localization element.

FIG. 2B illustrates retraction of the localization element.

FIG. 2C is a black-and-white image of the localization element attachedto a tracking wire.

FIG. 3A illustrates a close-up perspective view of a tip of a deliveryneedle during deployment of the localization element.

FIG. 3B illustrates a close-up bottom perspective view of the tip of thedelivery needle during deployment of the localization element.

FIG. 3C illustrates a close-up perspective view of a tip of the deliveryneedle after deployment of the localization element.

FIG. 3D illustrates a close-up bottom perspective view of the tip of thedelivery needle after deployment of the localization element.

FIG. 3E illustrates a close-up side view of the tracking wire beingpulled out of the delivery needle after deployment of the localizationelement.

FIG. 3F illustrates a close-up perspective view of the tracking wirebeing pulled out of the delivery needle after deployment of thelocalization element.

FIG. 4A is a perspective view of a knob and handle of the tissuelocalization device.

FIG. 4B is a cutaway view illustrating a part of the interior of thetissue localization device.

FIG. 5A is a cutaway view illustrating another part of the interior ofthe tissue localization device.

FIG. 5B is a cutaway view illustrating yet another part of the interiorof the tissue localization device.

FIG. 5C is a cutaway view illustrating another part of the interior ofthe tissue localization device.

FIG. 6A is a cutaway view illustrating a tactile and/or audible feedbackmechanism of the tissue localization device.

FIG. 6B is another cutaway view illustrating the tactile and/or audiblefeedback mechanism of the tissue localization device.

FIG. 6C is a front cutaway view illustrating the tactile and/or audiblefeedback mechanism of the tissue localization device.

FIG. 6D is a perspective cutaway view illustrating the tactile and/oraudible feedback mechanism of the tissue localization device.

FIG. 6E is a side cross-sectional view illustrating the tactile and/oraudible feedback mechanism of the tissue localization device.

FIG. 6F is a front cutaway view illustrating the tactile and/or audiblefeedback mechanism of the tissue localization device.

FIG. 6G is a perspective cutaway view illustrating the tactile and/oraudible feedback mechanism of the tissue localization device.

FIG. 6H is a side cross-sectional view illustrating the tactile and/oraudible feedback mechanism of the tissue localization device.

FIG. 6I is a front cutaway view illustrating the tactile and/or audiblefeedback mechanism of the tissue localization device.

FIG. 6J is a perspective cutaway view illustrating the tactile and/oraudible feedback mechanism of the tissue localization device.

FIG. 6K is a side cross-sectional view illustrating the tactile and/oraudible feedback mechanism of the tissue localization device.

FIG. 7 is an exploded view of the tissue localization device.

FIG. 8A illustrates a target tissue region, the localization element andthe delivery needle inside a patient tissue model.

FIG. 8B illustrates the localization element surrounding a target tissueregion or mass and the delivery needle exiting the patient tissue model.

FIG. 8C illustrates the localization element surrounding the targettissue region and a distal end of the tracking wire positioned outsideof the patient tissue model.

FIG. 9 illustrates an exploded view of another variation of the tissuelocalization device.

FIGS. 10A and 10B illustrate perspective and side views, respectively,of the assembled tissue localization device of FIG. 9.

FIGS. 10C and 10D illustrate side and perspective cut-away views,respectively, of the assembled tissue localization device of FIG. 9.

FIGS. 11A and 11B illustrate top and bottom perspective views,respectively, of a localization element detached from a pusher element.

FIGS. 11C and 11D illustrate top and bottom perspective views,respectively, of a localization element detachably held by a pusherelement.

FIGS. 11E and 11F illustrate top and bottom perspective views,respectively, of a tracking wire rotated relative to a localizationelement when the localization element is detached from a pusher element.

FIG. 12 illustrates an exploded view of another variation of the tissuelocalization device.

FIG. 13A illustrates a perspective view of a localization elementdeployed out of a delivery needle by a pusher element covered by apolymer liner.

FIGS. 13B and 13C illustrate perspective and side views, respectively,of a localization element detached from a pusher element partiallyseparated from a polymer liner.

FIGS. 14A and 14B illustrate a variation of a delivery needle having aneedle dimple.

FIG. 14C illustrates a close-up of a beveled distal end of a variationof a delivery needle.

FIG. 14D illustrates a close-up of a variation of a pusher elementcovered by a polymer liner extending out of the beveled distal end.

FIG. 14E illustrates a cross-section of the delivery needle enclosingthe pusher element covered by the polymer liner along line A-A shown inFIG. 14D.

FIG. 15A illustrates a tracking wire coupled to an end of a variation ofa localization element.

FIG. 15B illustrates a tracking wire coupled to a midpoint along alength of a variation of a localization element.

FIG. 15C illustrates a side view of a tracking wire coupled to an end ofa variation of a localization element.

FIG. 15D illustrates a perspective view of a tracking wire coupled to anend of a variation of a localization element.

FIG. 15E illustrates a tracking wire coupled to a midpoint along alength of a variation of a localization element.

FIG. 15F illustrates a tracking wire coupled to a point in between amidpoint and an end of a variation of a localization element.

FIG. 16 illustrates a variation of a localization element in a partialhelical configuration.

FIG. 17 illustrates a locator distal end of a variation of alocalization element with branched locator tips.

FIG. 18A illustrates a deployment of a localization element around asuspect tissue mass.

FIG. 18B illustrates a halo deployment of a localization element above asuspect tissue mass.

FIG. 18C illustrates a side view of a halo deployment of a localizationelement above a suspect tissue mass.

FIG. 18D illustrates a perspective view of the halo deployment of thelocalization element above a suspect tissue mass.

FIG. 18E is another perspective view of a halo deployment of alocalization element above a suspect tissue mass.

FIG. 19A illustrates a segment of a flexible tracking wire extending outfrom a patient's tissue and coiled to reduce the excess length of thetracking wire.

FIG. 19B illustrates a segment of a flexible tracking wire extending outfrom breast tissue.

FIG. 19C illustrates a segment of tracking wire coiled and taped tobreast tissue.

FIG. 20A illustrates a distal end of a multi-filament tracking wire.

FIG. 20B illustrates a distal end of a multi-filament tracking wirehaving a welded end.

FIGS. 20C-D illustrate an example cross-section of an attachment site ofa multi-filament tracking wire covered by a polymer jacketing.

FIG. 21 illustrates a variation of a method of operating the tissuelocalization device.

FIG. 22 illustrates another variation of a method of operating thetissue localization device.

FIGS. 23A-G illustrate a variation of a method of operating the tissuelocalization device.

FIGS. 24A-G illustrate examples of a localization element surface.

FIGS. 25A-C illustrate a variation of a pusher element.

FIG. 26 illustrates a variation of a localization element including oneor more barbs.

FIG. 27 illustrates a variation of the tissue localization deviceincluding a stainless steel liner.

FIGS. 28A-B illustrate an example of a spring coupled to the stainlesssteel liner.

FIGS. 29A-J illustrate example retraction locks.

FIGS. 30A-B illustrate an example setup for using the tissuelocalization device during imaging.

FIGS. 31A-B illustrate variations of a tissue localization wire.

FIG. 32A-B illustrate variations of using a stabilization sling.

DETAILED DESCRIPTION

FIGS. 1A, 1B, and 1C illustrate that a tissue localization device 100can include a handle 102 coupled to a delivery needle 104. The handle102 can include a handle grip 106, a knob portion 108, and a handle nose110. The handle grip 106 can be a portion of the handle 102 configuredto be grasped or held by a user such as a surgeon, radiologist or otherimaging professional. The handle grip 106 can be sized or shaped for auser to grasp the handle 102 with one hand. The handle grip 106 can beshaped as a cylinder, a tube, a rod, or combinations thereof. In othervariations, the handle grip 106 can be shaped as an elongate ovoid,prism, ellipsoid, cone, or combinations thereof. The handle grip 106 canhave finger grooves, holes, indentations, or combinations thereof.

The handle grip 106 can be connected to or contiguous with a knobportion 108. The knob portion 108 can be a portion of the handle 102housing a knob 112 for controlling the tissue localization device 100.The knob portion 108 can include an orientation arch 114. Theorientation arch 114 can be a curved protuberance extending out from asurface of the handle 102. The orientation arch 114 can help a userproperly orient the tissue localization device 100 by informing the userof the deployed curvature of a localization element 116. For example,the orientation arch 114 can have a half-oval or bow-shaped curvaturedenoting a direction and/or plane of curvature of the localizationelement 116 when deployed.

The knob 112 can be barrel or ellipsoid-shaped component for controllingthe deployment or retraction of the localization element 116. The knob112 can be a separate component attached to the handle 102 at the knobportion 108. The knob 112 can be positioned in proximity to theorientation arch 114. The knob 112 can have longitudinal ridges orgrooves. The longitudinal ridges or grooves of the knob 112 can allow auser to more easily rotate the knob 112. The knob 112 can be rotated ina clockwise direction, a counterclockwise direction, or combinationsthereof. The knob 112 can freely rotate until the localization element116 is deployed out of the tissue localization device 100. A user canhold the handle grip 106 of the handle 102 with one hand and use thefingers of the same hand to rotate the knob 112 to control thedeployment or retraction of the localization element 116.

The knob portion 108 can be connected to or contiguous with the handlenose 110. The handle nose 110 can be a portion of the handle 102 coupledto or housing a portion of the delivery needle 104. The handle nose 110can include a nozzle or luer end 118. The luer end 118 can fixedlysecure a packaging needle cover tube (not shown) to the handle 102. Theluer end 118 can be cross-shaped, conical, rectangular, frustoconical,or combinations thereof.

The handle 102, the knob 112, or combinations thereof can be fabricatedfrom or made of a polymer such as an injection molded polymer. Forexample, the handle 102, the knob 112, or combinations thereof can becomposed of or comprise acrylonitrile butadiene styrene (ABS) plastic,polycarbonate, polypropylene (PP), or combinations thereof. The handle102 can also be fabricated from or include parts fabricated fromglass-filled polymers, metals or metal alloys such as stainless steel,or combinations thereof.

The handle 102 can have a longitudinal dimension of between 100.0 mm and200.00 mm. For example, the handle 102 can have a longitudinal dimensionof approximately 155.0 mm. When the handle grip 106 is shaped as acylinder, the handle grip 106 can have a diameter between 9.0 mm and13.0 mm. For example, the handle grip 106 can have a diameter ofapproximately 11.0 mm.

The delivery needle 104 can include a needle tip 120 and a needle base122. The needle tip 120 can be an end of the delivery needle 104 forpuncturing the skin of a patient and deploying the localization element116. The delivery needle 104 can have a needle lumen. The needle lumencan be a hollow cavity within the delivery needle 104 for storing orhousing the localization element 116, a tracking wire 126, a portiontherein, or combinations thereof.

The needle tip 120 can have a beveled or deflected tip or point. Theneedle tip 120 can also include a blade, a sharpened edge, or a cuttingedge. For example, the needle tip 120 can include a hypodermic pointbevel, an intradermal point bevel, a deflected point septum, orcombinations thereof. The needle tip 120 can also have a bevel angle ofbetween 15 degrees and 45 degrees.

The needle base 122 can be partially housed or secured by the luer end118, the handle nose 110, other internal handle components, orcombinations thereof. The delivery needle 104 can include one or moredepth markers 124 in between the needle tip 120 and the needle base 122.The depth markers 124 can be markings, etchings, or surface indentationson the surface of the delivery needle 104 in between the needle tip 120and the needle base 122. The depth markers 124 can assist a user, suchas a surgeon, radiologist or other imaging professional, to insert thedelivery needle 104 into the tissue site of the patient. The depthmarkers 124 can be separated by increments of millimeters, centimeters,inches, or combinations thereof.

The delivery needle 104 can be made of metal, a metal alloy such asstainless steel, or a rigid medical grade polymer. The delivery needle104 can have a diameter of between 0.5 mm and 1.5 mm. The deliveryneedle 104 can have a diameter of approximately 1.0 mm.

The delivery needle 104, for example when made from a rigid medicalpolymer, can include or be covered by a radiopaque material or coating.The radiopaque material or coating can include gold or gold coating,platinum or platinum coating, tungsten or tungsten coating, iridium oriridium coating, tantalum or tantalum coating, barium sulfate, rhodium,or combinations thereof.

The delivery needle can have an echogenic surface such as can begenerated by sandblasting or beadblasting on portions of the needle,such as at the distal tip, for example, to enhance visualization of theneedle or portions thereof during clinical ultrasound imaging.

FIGS. 1A and 1B illustrate that the localization element 116 can becurved or loop-shaped when deployed. The localization element 116 can bea flexible wire or length of metal, polymer, or combinations thereofcombinations thereof. The localization element 116 can take on anarcuate, curvilinear, or looping shape when deployed out of the deliveryneedle 104. The localization element 116 can penetrate tissue and serveas a boundary or guidance marker for a tissue mass for subsequentremoval and/or analysis.

FIGS. 1A and 1B also illustrate that the tissue localization device 100can include a tracking wire 126. The tracking wire 126 can be coupled orconnected to the localization element 116. The tracking wire 126 can bemade of metal, a metal alloy such as stainless steel, or a medical gradepolymer, a stainless steel cable with polymer jacketing, a polymerthread, a polymer tube, or combinations thereof. The tracking wire 126can include or be covered by a radiopaque material, for example, forenhanced visualization of the tracking wire 126 when imaged.

The tracking wire 126 can be used to track the deployment or insertionpath of the delivery needle 104, the localization element 116, orcombinations thereof combinations thereof into the patient. The trackingwire 126, or a portion therein, can be housed within the handle 102 whenthe localization element 116 is not deployed or not fully deployed. Asegment of the tracking wire 126 can also be located outside the handle102 when the localization element 116 is not deployed or not fullydeployed. For example, a segment of the tracking wire 126 can extend outof an end of the handle 102 proximate to the handle grip 106 when thelocalization element 116 is not deployed or not fully deployed.

FIG. 2A illustrates that the localization element 116 can have adeployment trajectory 200 when deployed from the delivery needle 104.The deployment trajectory 200 can include a substantiallytwo-dimensional or planar trajectory along a substantiallytwo-dimensional plane. For example, the deployment trajectory 200 caninclude a substantially two-dimensional trajectory along a planebisecting a longitudinal axis of the tissue localization device 100. Inother variations, the deployment trajectory 200 can include athree-dimensional trajectory.

The localization element 116 can follow its deployment trajectory 200 toachieve a predetermined shape 202. The predetermined shape 202 caninclude a circular shape, an oval, a spiral shape, or combinationsthereof combinations thereof. In other variations, the predeterminedshape 202 can include a triangular shape, a rectangular shape, atrapezoidal shape, or combinations thereof combinations thereof. Thedeployment trajectory 200 can be a trajectory or path mimicking orfollowing such a predetermined shape 202. For example, the localizationelement 116 can have the predetermined shape 202 of a two-dimensionalcircle and the localization element 116 can emerge from the deliveryneedle 104 in a circular trajectory.

For example, the localization element 116 can have predetermined shape202 of a circle or loop having a diameter of between 10.0 to 40.0 mm.The localization element 116 can have a predetermined shape 202 of acircle or loop having a diameter of approximately 25.0 mm.

FIG. 2A illustrates that the localization element 116 can be deployedfrom the delivery needle 104 when the knob 112 is turned in a firstrotational direction 204. The first rotational direction 204 can includea clockwise rotational direction or a counterclockwise rotationaldirection when viewed along the longitudinal axis of the tissuelocalization device 100 from the handle grip 106 to the handle nose 110.

For example, the localization element 116 can exit or emerge out of theneedle tip 120 of the delivery needle 104 when the knob 112 is turned inthe first rotational direction 204. The localization element 116 canexit or emerge out of the needle tip 120 in a reverse loop trajectoryrepresenting the deployment trajectory 200 of the localization element116. The reverse loop trajectory can be a substantially circulartrajectory curving backward toward the needle base 122 of the deliveryneedle 104. The localization element 116 can initially curve upward orin a direction toward the apex or top of the orientation arch 114 beforelooping backwards toward the needle base 122. In other variations, thelocalization element 116 can initially curve downward or in a directionaway from the apex or top of the orientation arch 114 before loopingbackwards toward the needle base 122.

FIG. 2B illustrates that the localization element 116 can be retractedinto the delivery needle 104 when the knob 112 is turned in a secondrotational direction 206. The second rotational direction 208 can be adifferent rotational direction than the first rotational direction 204.The second rational direction can include a counterclockwise rotationaldirection or a clockwise rotational direction when viewed along thelongitudinal axis of the tissue localization device 100 from the handlegrip 106 to the handle nose 110.

The localization element 116 can have a retraction trajectory 208 whenretracting back into the delivery needle 104. The retraction trajectory208 can be the reverse or opposite of the deployment trajectory 200. Forexample, when the deployment trajectory 200 is an upward curving looptrajectory as shown in FIG. 2A, the retraction trajectory 208 is adownward curving loop trajectory as shown in FIG. 2B. The retractiontrajectory 208 can be a substantially two-dimensional trajectory, athree-dimensional trajectory, or combinations thereof combinationsthereof.

The localization element 116 can re-enter or retract back into theneedle tip 120 of the delivery needle 104 when the knob 112 is turned inthe second rotational direction 208. The localization element 116 canre-enter or retract back into the needle tip 120 by reversing orretracing the deployment trajectory 200 of the localization element 116.

FIG. 2C illustrates that the localization element 116 can be in acircular shape representing the predetermined shape 202. Thelocalization element 116 can have a predetermined shape 202 set by usingshape memory techniques, heating techniques, bending techniques, orcombinations thereof combinations thereof. The localization element 116can be composed of or fabricated from spring steel, a nickel-titaniumalloy such as Nitinol™, a shape memory polymer, stainless steel, orcombinations thereof combinations thereof.

The localization element 116 can include or be covered by a radiopaquematerial or coating. The radiopaque material or coating can include goldor gold coating, platinum or platinum coating, tungsten or tungstencoating, iridium or iridium coating, tantalum or tantalum coating,barium sulfate, rhodium, hydrophilic and other lubricious coatings, orcombinations thereof.

FIG. 3A illustrates that the tissue localization device 100 can includea pusher element or pusher element 300. The pusher element 300 can beused by the tissue localization device 100 to deploy the localizationelement 116. The pusher element 300 can be positioned inside thedelivery needle 104 when the localization element 116 resides in thedelivery needle 104. The pusher element 300 can slidably movelongitudinally within the delivery needle 104. The pusher element 300can be advanced longitudinally forward or longitudinally backwardthrough the delivery needle 104 when a user turns the knob 112 in thefirst rotational direction 204 or the second rotational direction 208,respectively. The pusher element 300 can be composed of or fabricatedfrom a polymer, stainless steel, or combinations thereof.

The pusher element 300 can include a pusher tip 302. The pusher tip 302can be a portion of the pusher element 300 removeably attached to thelocalization element 116. The pusher tip 302 can have a window 304. Thewindow 304 can be a partial opening or cutaway section along the pushertip 302.

The localization element 116 can include an element base 308 and anelement tip 306. The element base 308 can be a portion of thelocalization element 116 configured to be removeably attached to thepusher element 300. The element tip 306 can be an end of thelocalization element 116 distal to the element base 308. The element tip306 can be configured to pierce or cut through patient tissue. Theelement tip 306 can have a beveled edge, a sharpened edge, a pointedtip, or combinations thereof.

FIG. 3B illustrates that the element base 308 of the localizationelement 116 can include an eyelet frame 310, a narrow portion 312, and ashoulder 314. The eyelet frame 310 can be connected to the shoulder 314by the narrow portion 312. The eyelet frame 310 can have an eyelet 316.The eyelet 316 can be an opening or bore configured to receive thetracking wire 126. The tracking wire 126 can be threaded through theeyelet 316 and the threaded end can be connected, for example bycrimping via a ferrule or tied, to the remainder of the tracking wire126 using a crimp sleeve, a tie, a knot, an adhesive, a coil, heatshrink polymer jacketing, or combinations thereof.

The eyelet frame 310 can fit within the window 304 of the pusher element300 to allow the pusher element 300 to engage with the localizationelement 116. The portion of the pusher element 300 distal to the window304 can partially surround the narrow portion 312 of the element base308 when the eyelet frame 310 is within the window 304.

FIG. 3B illustrates that the pusher element 300 can advance thelocalization element 116 out of the delivery needle 104 by pushing onthe shoulder 314 of the localization element 116. The pusher element 300can also retract or draw the localization element 116 into the deliveryneedle 104 by pulling on the eyelet frame 310. The pusher element 300can retract the localization element 116 back into the delivery needle104 as long as the eyelet frame 310, the narrow portion 312, orcombinations thereof do not disengage from the pusher tip 302 of thepusher element 300. The eyelet frame 310 can disengage from the pushertip 302 when the eyelet frame 310 is displaced out of the window 304 ofthe pusher element 300. The narrow portion 312 can disengage from thepusher tip 302 when the narrow portion 312 and eyelet frame 310 are nolonger surrounded by the distal portion of the pusher element 300. Whenthe localization element resides within tissue, the shape memory of thelocalization element causes the proximal portion of the localizationelement to pull away from the pusher tip 302 once the narrow portion 312and eyelet frame 310 are no longer constrained by the pusher element300.

FIGS. 3C-3F illustrate that the localization element 116 can be deployedwhen the pusher tip 302 of the pusher element 300 no longer engages withthe element base 308. FIGS. 3C and 3D also illustrate that the trackingwire 126 can be pulled through the pusher element 300, the deliveryneedle 104, or combinations thereof once the localization element 116 isdeployed. The tracking wire 126 can be pulled through the pusher element300, the delivery needle 104, or combinations thereof when the userretracts the delivery needle 104 out of the patient after thelocalization element 116 is deployed. The entire length of the trackingwire 126 can be pulled through the handle 102, the delivery needle 104,the pusher element 300, or combinations thereof once the user has fullyretracted the delivery needle 104 out of the patient.

FIG. 4A illustrates that the tissue localization device 100 can becontrolled by the knob 112. A user can rotate the knob 112 in the firstrotational direction 204 to advance the localization element 116 towardthe needle tip 120 or out of the delivery needle 104. A user can alsorotate the knob 112 in the second rotational direction 208 to retractthe localization element 116 back into the needle tip 120 or furtherinto the delivery needle 104. The localization element 116 can beadvanced or retracted when the pusher tip 302 of the pusher element 300pushes or pulls, respectively, on the element base 308 of thelocalization element 116.

FIG. 4B illustrates that the tissue localization device 100 can have adrive pipe 400 positioned within the handle 102. The drive pipe 400 canextend from the handle grip 106 to the handle nose 110. The drive pipe400 can rotate within the handle grip 106. A portion of the drive pipe400 along the knob portion 108 can be surrounded or defined by an innerbarrel 402. The inner barrel 402 can be configured to interact with theknob 112 to allow the knob 112 to rotate the drive pipe 400.

For example, a user can rotate the knob 112 in a first rotationaldirection 204 to rotate the drive pipe 400 in the same first rotationaldirection 204. Also, for example, the user can rotate the knob 112 in asecond rotational direction 208 to rotate the drive pipe 400 in the samesecond rotational direction 208.

The drive pipe 400 can be fabricated from or made of a polymer such asan injection molded polymer. For example, the drive pipe 400 can becomposed of or comprise acrylonitrile butadiene styrene (ABS) plastic,polycarbonate, polypropylene (PP), or combinations thereof. The drivepipe 400 can also be fabricated from or include parts fabricated frommetals or metal alloys such as stainless steel.

FIG. 5A illustrates that the drive pipe 400 can have a pipe lumen 500.The pipe lumen 500 can be the interior or inside surface of the drivepipe 400. FIG. 5A also illustrates that the tissue localization device100 can have a car 502 residing inside the pipe lumen 500. The car 502can be a component of the tissue localization device 100 configured tomaneuver (e.g., push or pull) the pusher element 300. The car 502 can beshaped as an elliptic cylinder having a trivial height dimension. Forexample, the car 502 can be shaped as an elliptic cylinder having aheight dimension of between 1.0 mm and 4.5 mm. In other variations, thecar 502 can be shaped as a flattened rectangle, an oval disc, a circulardisc, or combinations thereof.

The car 502 can be within a car track 510. The car track 510 can be anelongate channel segment having a surface and walls that support the car502 as the car 502 slides along the central, longitudinal axis of thehandle. The car track 510 can be part of a rod or shaft having aconcavity or depression along a longitudinal length of the rod or shaft.The car 502, or a portion therein, can fit within the concavity ordepression of the car track 510. The car track 510 can be coupled to thedelivery needle 104. In other variations, the car track 510 can beseparate from the delivery needle 104. The car track 510 can reside orbe disposed in the pipe lumen 500. The car track 510 can remainstationary as the drive pipe 400 rotates.

The pusher element 300 can be attached to the car 502. The pusherelement 300 can be fixedly attached to the car 502 via adhesives,interference fit, screws, or combinations thereof. The pusher element300 can be attached to the car 502 by being threaded or molded throughthe body of the car 502. The pusher element 300 can be attached to a carfront portion 504. The car front portion 504 can be an end or segment ofthe car 502 proximal to the handle nose 110. The pusher element 300 canbe attached to, contiguous with, or extend out from the car frontportion 504.

The car 502 can include a car tooth 506. The car tooth 506 can be aprojection or protuberance extending out of the car 502. The car tooth506 can extend out vertically in a direction perpendicular to alongitudinal axis of the tissue localization device 100. The car tooth506 can also extend out in the direction of the apex or top of theorientation arch 114. The car tooth 506 can be shaped as a cube or atrapezoid. The car tooth 506 can have rounded or beveled edges orcorners. In other variations, the car tooth 506 can be ovoid,half-spherical, conical, frustoconical, or combinations thereof.

FIGS. 5A and 5B illustrate that the pipe lumen 500 can include a spiralchannel that extends radially inward from the surface of the pipe lumeninto the inner surface of the drive pipe 400. Solid material between thespiral channels is shown for example as region 508.

As the knob is turned in one rotational direction, it causes the spiralchannel to advance the car, thereby advancing the pusher tube, therebycausing the localization element 116 to advance from within the deliveryneedle 104. When the knob is manually turned in the opposite rotationaldirection, the process is reversed, causing the localization element 116to retract within the delivery needle 104.

FIG. 5C illustrates that the car 502 can be propelled by the drive pipe400 until the car 502 reaches the end of the pipe lumen 500 at thehandle nose 110 portion of the handle 102. The car 502 can come to astop when the car tooth 506 is passed to an end gear 514. The end gear514 can be the protruding gear 508 closest to the nozzle end 118. Theend gear 514 can be the last protruding gear 508 in the pipe lumen 500before the end of the pipe lumen 500.

The car 502 can come to a stop or be prevented from moving when the carfront portion 504 makes contact with or pushes against a car stop 512.The car stop 512 can be a stationary raised edge or protruding surfacefeature at the end of the pipe lumen 500 proximal to the luer end 118.In other variations, the car stop 512 can be a separate stationarycomponent of the tissue localization device 100 coupled to the nozzleend 118.

The drive pipe 400, the knob 112, or combinations thereof can beprevented from rotating further in the first rotational direction 204when the car 502 reaches the car stop 512. The drive pipe 400, the knob112, or combinations thereof can be prevented from rotating in the firstrotational direction 204 when the end gear 514 pushes against the cartooth 506 of the stopped car 502. The car tooth 506 of the stopped car502 can block the further angular rotation of the end gear 514.

The drive pipe 400 can be rotated in the second rotational direction 208to push the car 502 away from the car stop 512 and toward the oppositeend of the pipe lumen 500. When the drive pipe 400 is rotated in thesecond rotational direction 208, the end gear 514 can also rotate in thesecond rotational direction 208 and apply a force to the car tooth 506in the direction of handle grip 106.

FIGS. 6A and 6B illustrate that the tissue localization device 100 caninclude a rotational alert 600, such as a tactile feedback orsound-generating alert. The rotational alert 600 can be configured togenerate an audible and/or tactile signal or indication to a user of thetissue localization device 100 that the localization element 116 isabout to deploy and detach and no longer instantly retractable. Thesignal or indication can include tactile clicking or vibration, audibleclicking noises, tapping sensations and/or noises, grinding sensationsand/or noises, increased rotational resistance, squealing, scraping,scratching, or combinations thereof. The rotational alert 600 caninclude a rod, a pin, a hook, a spring, or combinations thereofprotruding from the car front portion 504.

The drive pipe 400 can include a grooved section 602. The groovedsection 602 can be a portion of the drive pipe 400 having longitudinalgrooves 604 around a circumference of the pipe lumen 500. The rotationalalert 600 can interact with the longitudinal grooves 604 to generate theaudible and/or tactile signal. The rotational alert 600 can interactwith the longitudinal grooves 604 when the car 502 enters the groovedsection 602. The grooved section 602 can be in the vicinity of the carstop 512. The rotational alert 600 can interact with the longitudinalgrooves 604 as the pipe lumen 500 rotates in the first rotationaldirection 204, the second rotational direction 208, or combinationsthereof. The pipe lumen 500 can rotate the longitudinal grooves 604 inthe first rotational direction 204, the second rotational direction 208,or combinations thereof. The rotational alert 600 can tap or dragagainst the longitudinal grooves 604 to generate the detectable audibleand/or tactile signal.

The rotational alert 600 can generate the audible and/or tactile signalto inform the user that the car 502 has pushed the pusher tip 302 of thepusher element 300 out of the delivery needle 104. The audible and/ortactile signal can also indicate that the element base 308 of thelocalization element 116 can soon become dislodged or separated from thepusher tip 302 of the pusher element 300.

The grooved section 602 can be a portion of the drive pipe 400 in thehandle nose 110 of the handle 102. The rotational alert 600 can generatethe audible and/or tactile signal until the car reaches the car stop512.

FIGS. 6C, 6D, and 6E illustrate that the rotational alert 600 can have arotational alert tip 606. The rotational alert tip 606 can be an end ofthe rotational alert 600 distal to the car front portion 504. Therotational alert tip 606 can be a curved or coiled tip of an elongaterod representing the body of the rotational alert 600. FIGS. 6C, 6D, and6E illustrate that the rotational alert 600, the rotational alert tip606, or combinations thereof can proceed down the pipe lumen 500 withoutgenerating any noticeable audible and/or tactile alert signals or noisesas the car 502 is pushed through the pipe lumen 500 toward the handlenose 110.

FIGS. 6F, 6G, and 6H illustrate that the rotational alert tip 606 can bepositioned within a longitudinal groove 604 when the rotational alert600 enters the grooved section 602 of the drive pipe 400. The groovessection 602 can have longitudinal ridges 608 separated by longitudinalgrooves 604. The longitudinal ridges 608 can protrude radially inwardtoward the center of the pipe lumen 500.

The rotational alert 600 can generate an audible and/or tactile signalor feedback when the drive pipe 400 is rotated in either the firstrotational direction 204 or the second rotational direction 208 when therotational alert tip 606 is in the grooved section 602. The rotationalalert 600 can generate the audible and/or tactile signal or feedback asthe rotational alert tip 606 makes contact with the longitudinal ridges608, the longitudinal grooves 604, or combinations thereof as the drivepipe 400 is rotated.

FIGS. 6I, 6J, and 6K illustrate that the rotational alert tip 606 can bedeflected by the longitudinal ridges 608 when the drive pipe 400 isrotated in either the first rotational direction 204 or the secondrotational direction 208. The rotational alert tip 606 can be deflectedwhen the rotational alert 600 is pushed radially inward by thelongitudinal ridges 608. For example, when the rotational alert 600 is arod having a curved or hooked end representing the rotational alert tip606, the curved or hooked end can be deflected by the longitudinalridges 608 as the drive pipe 400 is rotated by the knob 112. In thisexample, the rod and the curved or hooked end can be pushed radiallyinward when the curved or hooked end is deflected by the longitudinalridges 608.

FIG. 7 illustrates that the drive pipe 400 can be positioned within thehandle 102 when the tissue localization device 100 is in an assembledstate. The car track 510 can be coupled to the delivery needle 104 andboth the car track 510 and the delivery needle 104 can be positionedwithin the drive pipe 400 when the tissue localization device 100 is inthe assembled state. The car 502 can be fixedly attached to the pusherelement 300. The pusher element 300 can be threaded through the deliveryneedle 104 and can be positioned in the delivery needle 104 when thetissue localization device 100 is in the assembled state. Thelocalization element 116 can be coupled to the tracking wire 126. Thetracking wire 126 can be threaded through the pusher element 300 beforethe pusher element 300 is inserted into the delivery needle 104. Thelocalization element 116 can be removably attached to the pusher tip 302of the pusher element 300. The localization element 116 can also bepressed into a straightened configuration to be inserted into thedelivery needle 104.

FIG. 8A illustrates that the localization element 116 can surround atarget tissue 700, for example having or being a target tissue mass,when deployed in a patient tissue model. The localization element 116can cut through the patient's tissue, such as a breast tissue or lungtissue, as the pusher element 300 and the car 502 are pushedlongitudinally through the pipe lumen 500. The localization element 116can curve into the predetermined shape 202 to surround and mark thetarget tissue 700. The predetermined shape 202 can be a circular shape.The localization element 116 can be deployed from the tissuelocalization device 100 when the eyelet frame 310 of the localizationelement 116 is dislodged or otherwise becomes separated from the window304 of the pusher element 300. In addition, the localization element 116can be deployed when the narrow portion 312 of the localization element116, the shoulder 314, or combinations thereof is separated from thepusher tip 302 of the pusher element 300.

The user can complete the deployment of the localization element 116 byretracting the delivery needle 104, the pusher element 300, orcombinations thereof completely out of the patient's tissue site. Thelocalization element 116 can become anchored in the implantation site ofthe patient's tissue as the localization element 116 is separated fromthe rest of the tissue localization device 100.

FIG. 8B illustrates that the end of the tracking wire 126 coupled to thelocalization element 116 can remain in the patient's tissue prior toremoval of the delivery needle 104 from the tissue site. The trackingwire 126 can serve as a path or trail for informing a surgeon of thepath taken by the delivery needle 104 into the patient's appendage. Thetracking wire 126 can also serve as a path or trail for indicating thelocation of the target tissue region delineated by the curvedlocalization element 116.

FIG. 8C illustrates that the end of the tracking wire 126 not attachedor coupled to the localization element 116 can emerge from the patient'sskin after the delivery needle is removed. This exposed segment of thetracking wire 126 can be allowed to extend from the patient and becausethe wire 126 is flexible, the wire 126 can comfortably reside on thepatient's skin (with or without coiling it) and secured by, for example,adhesive dressing to the patient's skin. For example, the exposedsegment of the tracking wire 126 can be taped by surgical tape to thepatient's appendage. The exposed segment of the tracking wire 126 canalso be coiled, folded, twisted, or cut before or after being taped tothe patient's skin or dressing. The flexible nature of the tracking wire126 enables the patient to be comfortable while the localization elementremains in situ, with minimal risk of dislodgement of the localizationelement. This feature allows for logistic flexibility in planning forthe surgical removal of the localized tissue (e.g. place thelocalization element on one day and remove the tissue specimen andlocalization element on a subsequent day).

Although not shown in the figures, it is anticipated by this disclosurethat multiple localization elements 116 can be used to mark or surroundthe suspect tissue mass in three dimensions.

FIG. 9 illustrates that the tissue localization device 900 can have ahandle 902 with a slidable delivery control 904 and a delivery needle906 extending out from the handle 902. The handle 902 can be shaped as acylinder, a tube, a rod, an elongate ovoid, an ellipsoid, a cone, orcombinations thereof. The handle 902 can comprise finger grooves, holes,indentations, or combinations thereof. The handle 902 can be sized orshaped such that a user can grasp the handle 902 with one hand. Thehandle 902 can comprise or be composed of acrylonitrile butadienestyrene (ABS) plastic, polycarbonate, polypropylene (PP), or othersuitable polymers, or combinations thereof. The handle 902 can alsocomprise components fabricated from metals or metal alloys such asstainless steel.

The handle 902 can have a handle distal end 908, a handle proximal end910 opposite the handle distal end 908, a handle dorsal side 912, ahandle ventral side 914 opposite the handle dorsal side 912, and anelongate slot 916 defined along the handle dorsal side 912.

The handle distal end 908 can include a nozzle or luer end. The luer endcan fixedly secure a packaging needle cover (not shown in FIG. 9) toprotect the delivery needle 906.

The delivery needle 906 can also have a needle lumen 918 and a pusherelement 920 slidably translatable within the needle lumen 918. Thedelivery needle 906 can comprise or be composed of a metal, metal alloy,or a rigid medical grade polymer. When the delivery needle 906 is madeof a polymer, the delivery needle 906 can be covered with a radiopaquematerial or coating. The pusher element 920 can have a pusher distal end922 and a pusher proximal end 924 opposite the pusher distal end 922.

The pusher element 920 can have a pusher plug 926 affixed near thepusher proximal end 924. The pusher plug 926 can be affixed to astationary position along the pusher element 920. The pusher plug 926can have a number of threaded bores or holes defined along a dorsalsurface of the pusher plug 926. The delivery control 904 can beconnected to the pusher element 920 via fasteners 928 screwed into thethreaded bores or holes of the pusher plug 926. At least a portion ofeach of the fasteners 928 can extend through the elongate slot 916 whenthe delivery control 904 is coupled to the pusher element 920. In othervariations, the delivery control 904 can be connected to the pusher plug926 via adhesives, an interference or locking fit, clips, clasps, snapbuttons, wire connectors, insert molding, or combinations thereof. Theelongate slot 916 can act as a track or guiding lane for thelongitudinal translation of the delivery control 904. The deliverycontrol 904 can be pushed toward the handle distal end 908 or pulledtoward the handle proximal end 910 to translate the pusher element 920within the needle lumen 918.

The positioning or orientation of the delivery control 904 relative tothe handle 902 can indicate the deployment orientation of thelocalization element 930 relative to the handle 902. For example, thelocalization element 930 can deploy toward a side of the tissuelocalization device 900 on which the delivery control 904 is disposed.Alternatively, the localization element 930 can deploy toward anopposite side of the tissue localization device 900 from the deliverycontrol 904, or the delivery control 904 can have arrows pointing towarda direction of the localization element's deployment.

The tissue localization device 900 can also include a localizationelement 930 and a flexible tracking wire 932 coupled to the localizationelement 930. The tracking wire 932 can have a wire distal segment 934including a wire distal end 936 and a wire proximal segment 938including a wire proximal end 940.

The localization element 930 can be curled or curved into a deployedconfiguration 942 when unconstrained by or deployed from the deliveryneedle 906. The localization element 930 can be pressed or formed into aflat or unfurled configuration when positioned within the needle lumen918 of the delivery needle 906. The localization element 930 can beinitially positioned within the needle lumen 918 when the tissuelocalization device 900 is in the assembled state. The localizationelement 930 can slidably translate within the needle lumen 918. As willbe discussed in the following sections, the localization element 930 canbe detachably held by or can detachably interlock with the pusherelement 920 when the localization element 930 is within the needle lumen918.

FIG. 9 also illustrates that the handle 902 can have a number ofdeployment stage markers 944. The deployment stage markers 944 can begraphics, etchings, or indents along the outside surface of the handle902. The deployment stage markers 944 can inform a user of the extent ofthe deployment of the localization element 930 based on a position ofthe delivery control 904 relative to the deployment stage markers 944.The deployment stage markers 944 can include a starting marker 946, aninitial deployment marker 948, a halfway deployment marker 950, and adeployed marker 952.

The starting marker 946 can be a marker most proximal to the handleproximal end 910. The localization element 930 can be completely withinthe needle lumen 918 when the delivery control 904 is positioned behindthe starting marker 946. The initial deployment marker 948 can bepositioned distal to the starting marker 946. At least a portion of thelocalization element 930 can be located outside of the needle lumen 918when the delivery control 904 is positioned in between the startingmarker 946 and the initial deployment marker 948. The halfway deploymentmarker 950 can be positioned distal to the initial deployment marker948. At least half of the length of the localization element 930 can belocated outside of the needle lumen 918 when the delivery control 904 ispositioned in between the initial deployment marker 948 and the halfwaydeployment marker 950. The halfway deployment marker 950 can alsoindicate the point at which the localization element 930 can still beretracted back into the delivery needle 906. The deployed marker 952 canbe the marker closest to the handle distal end 908. The localizationelement 930 can be fully laterally deployed when the delivery control904 is positioned in between the halfway deployment marker 950 and thedeployed marker 952. The deployed marker 952 can also indicate the pointat which the localization element 930 can no longer be retracted backinto the delivery needle 906.

FIG. 9 also illustrates that the delivery needle 906 can have a numberof needle depth markers 954. The needle depth markers 954 can be locatedin between the needle tip and the needle base. The needle depth markers954 can be markings, etchings, or surface indentations on the surface ofthe delivery needle 906. The needle depth markers 954 can assist a user,such as a surgeon, radiologist or other imaging professional, to insertthe delivery needle 906 into the tissue of a patient. The needle depthmarkers 954 can be separated by increments of millimeters, centimeters,inches, or combinations thereof.

FIG. 10A illustrates that the delivery control 904 can include asubstantially triangular component having a first interface surface 1000and a second interface surface 1002. The first interface surface 1000and the second interface surface 1002 can be sloped or raised. The firstinterface surface 1000 can be upwardly concave when viewed from thehandle proximal end 910 to the handle distal end 908. The secondinterface surface 1002 can be upwardly concave when viewed from thehandle distal end 908 to the handle proximal end 910. In othervariations, the first interface surface 1000 and the second interfacesurface 1002 can be any shape or orientation needed to advance orretract the delivery control 904 with one hand of a user.

A method of operating the tissue localization device 900 can involve auser holding the handle 902 of the tissue localization device 900 usingone hand of the user. The method can also involve the user pushing thefirst interface surface 1000 of the delivery control 904 in a firstlongitudinal direction 1004 with at least one finger of the same handholding the handle 902. All references to finger in this disclosure caninclude one or more digit fingers, a thumb, a part of a finger, or anycombinations thereof. The first longitudinal direction 1004 can be aforward direction. For example, the delivery control 904 can be pushedin the first longitudinal direction 1004 from the starting marker 946 tothe initial deployment marker 948, the halfway deployment marker 950, orthe deployed marker 952. The localization element 930 can be translatedthrough the needle lumen 918 in response to the pushing or withdrawingof the delivery control 904.

In cases where the delivery control 904 is not pushed to the deployedmarker 952 or beyond, the method can further involve the user pulling orotherwise applying force to the second interface surface 1002 in thesecond longitudinal direction 1006. The second longitudinal direction1006 can be a backward direction opposite the first longitudinaldirection 1004. The localization element 930 can be retracted back intothe delivery needle 906 or further into the delivery needle 906 inresponse to the pulling of the delivery control 904.

The user can pull or otherwise apply force to the second interfacesurface 1002 with at least one finger of the same hand holding thehandle 902. In this manner, the tissue localization device 900 can beoperated entirely with one hand of the user. This feature is importantbecause, in many cases, the other hand of the user is simultaneouslybeing used to position an ultrasound transducer, thereby enabling theuser to position the delivery needle 906 and control the deployment andretraction of the localization element 930 via the handle 902 undersimultaneous ultrasound guidance.

FIG. 10B illustrates that the localization element 930 can be curledinto a deployed configuration 942 when the delivery control 904 istranslated to the deployed marker 952. FIGS. 10A and 10B also illustratethat at least a segment of the tracking wire 932, such as the wireproximal end 940, can extend out of the handle proximal end 910 when thedelivery control 904 is translated to the deployed marker 952. More ofthe tracking wire 932 can extend out of the handle proximal end 910 asthe delivery control 904 is pulled in the second longitudinal direction1006 toward the handle proximal end 910. The tracking wire 932 can behoused within a lumen of the pusher element 920 when the localizationelement 930 is detachably held by or detachably interlocks with thepusher element 920.

FIG. 10C illustrates that the handle 902 can have a handle lumen 1008.The pusher plug 926 and at least a segment of the pusher element 920 canbe housed within the handle lumen 1008. The pusher plug 926 and thepusher element 920 can also translate longitudinally within the handlelumen 1008.

FIG. 10C also illustrates that the handle 902 can have a handle length1010. For example, the handle length 1010 can be between approximately12.0 cm and 20.0 cm. The handle length 1010 can be approximately 16.0cm. FIG. 10C further illustrates that the delivery needle 906 can have aneedle length 1012. For example, the needle length 1012 can be betweenapproximately 10.0 cm and 15.0 cm. The needle length 1012 can beapproximately 12.0 cm. FIG. 10C also illustrates that the pusher element920 can have a pusher length 1014. For example, the pusher length 1014can be between approximately 16.0 cm to 20.0 cm. The pusher length 1014can be approximately 17.5 cm. FIG. 10C further illustrates that thetracking wire 932 can have a wire length 1016. For example, the wirelength 1016 can be between approximately 20.0 cm and 30.0 cm. The wirelength 1016 can also be greater than 30.0 cm depending on the locationof a target tissue site.

FIG. 10D illustrates that the fasteners 928 can extend into a portion ofthe delivery control 904 to connect the delivery control 904 to thepusher plug 926 and the pusher element 920. FIG. 10D also illustratesthat the elongate slot 916 can provide clearance for the fasteners 928as the delivery control 904, the pusher plug 926, and the pusher element920 translate longitudinally in the first longitudinal direction 1004 orthe second longitudinal direction 1006. FIG. 10D further illustratesthat connecting the delivery control 904 to the pusher element 920 viathe pusher plug 926 prevents the pusher element 920 from beingtranslated (e.g., pushed or pulled) entirely out of the handle lumen1008 or the needle lumen 918. In some variations, the tissuelocalization device 900 can comprise a gear mechanism and thetranslation of the pusher element 920 can be facilitated by the gearmechanism.

FIGS. 11A and 11B illustrate that the localization element 930 can havea locator proximal end 1100 and a locator distal end 1102. The locatordistal end 1102 can have a sharpened locator tip 1104 for piercingthrough tissue. The locator proximal end 1100 can include an eyeletframe 1106 surrounding an aperture 1108, a narrow portion 1110, and ashoulder portion 1112. The eyelet frame 1106 can be connected to theshoulder portion 1112 by the narrow portion 1110. The aperture 1108 canbe positioned substantially in the middle of the eyelet frame 1106. Theaperture 1108 can be an opening, hole, or bore configured to receive thetracking wire 932.

FIGS. 11A and 11B also illustrate that the pusher element 920 can have apusher dorsal side 1114 and a pusher ventral side 1116 opposite thepusher dorsal side 1114. A delivery port 1118 can be defined along thepusher dorsal side 1114 proximal to the pusher distal end 922. Thedelivery port 1118 can be a cutout along the pusher dorsal side 1114.The eyelet frame 1106 of the localization element 930 can be detachablypositioned within the delivery port 1118 of the pusher element 920 whenthe localization element 930 is within the needle lumen 918. The eyeletframe 1106, shoulder portion 1112, and narrow portion 1110 of thelocalization element 930 are collectively referred to herein as aninterlocking framework, which allows the localization element 930 toreleasably interlock with the pusher element 920. The movement ortranslation of the localization element 930 can be controlled by thedelivery control 904 when the interlocking framework is positionedwithin or interlocked with the delivery port 1118. In particular, theinterlocking of the localization element 930 and the pusher element 920by the interlocking framework allows longitudinal translation of thedelivery control 904 to slide the localization element 930 in both adistal and proximal direction within the delivery needle 906, bothpushing the localization element 930 out of the delivery needle 906 andretracting it into the delivery needle 906.

The localization element 930 can be deployed out of the delivery needle906 when the pusher distal end 922 pushes the shoulder portion 1112 ofthe localization element 930 in the first longitudinal direction 1004out of the delivery needle 906. The interlocking framework of thelocalization element 930 can release from the delivery port 1118 of thepusher element 920 when the delivery port 1118 exits the lumen of thedelivery needle 906. The localization element 930 can curl into asubstantially circular deployed configuration 942 when deployed. Thelocalization element 930 can curl or curve in a direction of the handledorsal side 912 when deployed out of the delivery needle 906.

The localization element 930 can comprise or be composed of a metal, ametal alloy, a polymer, or combinations thereof. In some variations, thelocalization element 930 can comprise or be composed of a shape-memorymaterial. For example, the localization element 930 can comprise or becomposed of a shape memory metal alloy such as Nitinol™. Thelocalization element 930 can penetrate tissue and serve as a boundary orguidance marker for a tissue mass for subsequent removal and/oranalysis.

The localization element 930 can be processed or finished so as toreduce the sliding friction between the localization element 930 and theinner surface of the needle lumen 918. For example, the localizationelement 930 can be electro-polished or mechanically polished. Thelocalization element 930 can also be covered by a blue-oxide finish. Thelocalization element 930 can be covered by the blue-oxide finish by heattreating the localization element 930 in a salt bath.

The localization element 930 can be a flexible length of metal or wire,a flexible length of polymer, a flexible length of shape-memorymaterial, or combinations thereof. The localization element 930 can takeon an arcuate, curvilinear, or looping shape when deployed out of thedelivery needle 906.1

The pusher distal end 922 can be sloped and form an obtuse angle withthe pusher ventral side 1116. The obtuse angle formed by the pusherdistal end 922 and the pusher ventral side 1116 can be seen when viewedfrom a lateral side of the tissue localization device 900. The slopeddesign of the pusher distal end 922 can allow the pusher element 920 tomore effectively push the shoulder portion 1112 of the localizationelement 930 in the first longitudinal direction 1004 without theshoulder portion 1112 curling upwards toward the top of the needle lumen918. This can reduce sliding friction between the localization element930 and the needle 918 as the localization element 930 is translatedthrough the needle lumen 918. The pusher distal end 922 can also form anacute angle with the pusher dorsal side 1114 when viewed from thelateral side of the tissue localization device 900.

As previously discussed, the movement or translation of the localizationelement 930 can be controlled by the delivery control 904 when theeyelet frame 1106 is positioned within the delivery port 1118. Thedelivery port 1118 can have a distal port side 1120, a proximal portside 1122, and a port base 1124. The distal port side 1120 can form anacute angle with the port base 1124 when viewed from the lateral side ofthe tissue localization device 900.

The localization element 930 can be retracted back into the deliveryneedle 906 even after at least a portion of the localization element930, such as the locator distal end 1102, has exited the needle lumen918. The localization element 930 can be retracted back into thedelivery needle 906 when the distal port side 1120 of the pusher element920 pulls on an eyelet shoulder 1113 in the second longitudinaldirection 1006. The pusher element 920 can be pulled in the secondlongitudinal direction 1006, for example, when a user applies a force tothe second interface surface 1002 of the delivery control 904 in thesecond longitudinal direction 1006.

The pusher element 920 can have a pusher lumen 1126. The narrow portion1110 of the localization element 930 can be positioned within a segmentof the pusher lumen 1126 when the eyelet frame 1106 is positioned withinthe delivery port 1118.

FIGS. 11A and 11B also illustrate that the tracking wire 932 can becoupled to the locator proximal end 1100 of the localization element930. The tracking wire 932 can be coupled or tied to the eyelet frame1106 of the localization element 930. The wire distal end 936 of thetracking wire 932 can be threaded through the aperture 1108 such that aloop 1128 forms around the eyelet frame 1106. The wire distal end 936can then be secured to another segment of the tracking wire 932 at anattachment site 1130. For example, the wire distal end 936 can besecured to an attachment site 1130 along the wire distal segment 934.More specifically, the wire distal end 936 can be welded or adhered withadhesive to another segment of the tracking wire 932 at a site servingas the attachment site 1130. In other variations, the wire distal end936 can be tied to another segment of the tracking wire 932 or crimpedto another segment of the tracking wire 932 using a ferrule.

The tracking wire 932 can comprise or be composed of a metal or metalalloy such as stainless steel. The tracking wire 932 can comprise or becomposed of a cable for flexibility, tensile strength, and low-profile.For example, the cable can be a 19-filament metal wire cable. In othervariations, the tracking wire 932 can comprise or be composed of abraided cable such as a high-tensile strength braided suture used insuch applications as orthopedic surgery.

A polymer jacketing 1132 can cover or ensheath at least part of thetracking wire 932. The polymer jacketing 1132 can also cover or ensheaththe attachment site 1130. The polymer jacketing 1132 can be aheat-shrink polymer or tube wrapped around the tracking wire 932. Atleast part of the tracking wire 932 can be positioned within the pusherlumen 1126, the needle lumen 918, and the handle lumen 1008 when thelocalization element 930 is detachably held by or detachably interlockswith the pusher element 920. By jacketing the side-by-side portions ofthe tracking wire 932, the tracking wire 932 behaves as one filament,making it easier for the clinician to handle the tracking wire 932 forexample during coiling or subsequently during surgical specimen removal.

Once the localization element 930 has detached from the pusher element920, the tracking wire 932 can exit the pusher lumen 1126 and the needlelumen 918 as the delivery needle 906 is retracted away from the deployedlocalization element 930. For example, the localization element 930 canbe deployed out of the delivery needle 906 within the tissue of apatient. In this example, an operator of the tissue localization device900 can slowly retract the delivery needle 906 out of the tissue of thepatient. As the delivery needle 906 is retracted out of the patient,more of the tracking wire 932 can be exposed. As will discussed in thefollowing sections, at least a segment of the tracking wire 932 canremain within the tissue of the patient after the delivery needle 906 isremoved from the patient.

FIGS. 11C and 11D illustrate that the movement or translation of thelocalization element 930 can be controlled by the delivery control 904when the eyelet frame 1106 is positioned within the delivery port 1118.The localization element 930 can automatically detach or be dislodgedfrom the pusher element 920 and the delivery needle 906 when at leastpart of the eyelet frame 1106 held by the delivery port 1118 istranslated by the delivery control 904 out of the delivery needle 906.For example, the localization element 930 can automatically separate,detach, or dislodge from the pusher element 920 when the eyelet frame1106 is pushed out of the needle lumen 918 and the localization element930 no longer constrained by the interior surface of the needle lumen918. The localization element 930 can be considered detached from thepusher element 920 when the eyelet frame 1106 is no longer positionedwithin the delivery port 1118. The rotational orientation of the pusherelement 920 as shown in FIG. 11D can improve automatic detachment of thelocalization element 930 from the pusher element 920. This orientationfacilitates the localization element 930 to move freely away from thepusher element 920 due to the inherent direction of motion imparted bythe shape memory of the localization element. This orientation allowsfor automatic separation from the interlocking connection between thepusher element 920 and localization element 930 once the interlockingframework of the localization element 930 is no longer constrained bythe bore of the delivery needle 906.

The localization element 930 can be retracted back into the deliveryneedle 906 when at least a portion of the eyelet frame 1106 is stillpositioned within the delivery port 1118.

FIGS. 11E and 11F illustrate that the tracking wire 932 coupled to thelocator proximal end 1100 can swivel or rotate relative to thelocalization element 930 when the localization element 930 is detachedfrom the rest of the tissue localization device 900. For example, theloop 1128 formed by the wire distal segment 934 can swivel or rotaterelative to the eyelet frame 1106.

FIGS. 11E and 11F illustrate that the spatial alignment of the trackingwire 932 can initially be positioned essentially tangential to acurvature of the deployed localization element 930. For example, thelocalization element 930 can curl into a circular shape when in thedeployed configuration 942 and the tracking wire 932 can initially bealigned tangent to the circular-shaped localization element 930. FIGS.11E and 11F also illustrate that the loop 1128 formed by the trackingwire 932 can subsequently swivel or rotate with respect to the eyeletframe 1106 typically due to movement of the proximal end of thelocalization element 930 as it becomes unconstrained by the needle lumen918. Once the loop 1128 swivels or rotates, the spatial alignment of thetracking wire 932 relative to the localization element 930 can change.For example, at least a segment of the tracking wire 932 can be alignedas a secant or in a non-tangential orientation relative to thecircular-shaped localization element 930 once the loop 1128 formed bythe wire distal segment 934 swivels or rotates.

The tracking wire 932 can automatically change its spatial alignmentrelative to the localization element 930 once the localization element930 is detached from the rest of the delivery system of the tissuelocalization device 900. For example, when the tracking wire 932 isaligned tangential to the curled localization element 930, thelocalization element 930 can be more susceptible to inadvertentdisplacement within the tissue of the patient when the tracking wire 932is pulled or when the patient moves. Changing the spatial alignment ofthe tracking wire 932 relative to the localization element 930 can makethe deployed localization element 930 more difficult to displace withinthe tissue of the patient by pulling on the tracking wire 932 or whenthe patient moves. In addition, changing the alignment of the trackingwire 932 relative to the localization element 930 from a tangentialalignment to a secant or non-tangential alignment can reduce the riskthat the localization element 930 inadvertently retracts out of thetissue of the patient when the tracking wire 932 is being pulled by thepatient or a health professional or when a patient moves.

FIG. 12 illustrates that the tissue localization device 900 can includea polymer liner 1200. The polymer liner 1200 can radially ensheath orsurround at least a portion of the pusher element 920, and can beslidably translatable in the delivery needle 906. The polymer liner 1200can prevent metal-on-metal contact between the outer surface of thepusher element 920 and at least a portion of the localization element930 as well as the surface of the needle lumen 918 as the pusher element920 is translated through the needle lumen 918. The liner 1200 can alsomove along with the pusher element 920 as the pusher element travelsthrough the delivery needle lumen thereby preventing metal from slidingagainst metal for the portion of the localization element 930 that isensheathed by the liner 1200. The polymer liner 1200 can be interposedor pressed between an outer surface of the pusher element 920 and thesurface of the needle lumen 918 or a portion of the localization element930 or tracking wire 932 and the surface of the needle lumen 918 inorder to reduce the static and/or dynamic frictional forces acted uponby the pusher element 920, the localization element 930 or tracking wire932 as the pusher element 920 travels through the needle lumen 918.

The needle lumen 918 can have a lumen dorsal surface 1202 and a lumenventral surface 1204. The lumen dorsal surface 1202 can refer to anupper portion or top half of the needle lumen 918. The lumen ventralsurface 1204 can refer to a lower portion or bottom half of the needlelumen 918. The polymer liner 1200 can completely encircle or surroundthe pusher element 920 such that no contact is made between the externalsurface of the pusher element 920 and the needle lumen 918 as the pusherelement 920 is translated longitudinally through the needle lumen 918.In another variation, the polymer liner 1200 can cover the pusher dorsalside 1114 and prevent the pusher dorsal side 1114 from contacting thelumen dorsal surface 1202 as the pusher element 920 is translatedlongitudinally through the needle lumen 918. The polymer liner 1200 cancover the pusher ventral side 1116 and prevent the pusher ventral side1116 from contacting the lumen ventral surface 1204 as the pusherelement 920 is translated longitudinally through the needle lumen 918.

The polymer liner 1200 can comprise or be fabricated from polyetherether ketone (PEEK). In other variations, the polymer liner 1200 cancomprise or be fabricated from any polymer or polymer blend (e.g., afluoropolymer) capable of facilitating the longitudinal translation ofthe pusher element 920 through the needle lumen 918.

The polymer liner 1200 can have a liner length 1206 substantiallyequivalent to the needle length 1012. In other variations, the needlelength 1012 can be greater than the liner length 1206.

FIGS. 13A to 13C illustrate that the polymer liner 1200 can include adorsal liner 1300 and a ventral liner 1302. The dorsal liner 1300 andthe ventral liner 1302 can combine to radially ensheath or surround thepusher element 920. The polymer liner 1200 can have a liner distalsegment 1304. The liner distal segment 1304 can extend from the pusherdistal end 922 to the proximal port side 1122.

FIG. 13B illustrates that the dorsal liner 1300 can separate from theventral liner 1302 when the liner distal segment 1304 is pushed ordeployed out of the needle lumen 918. The dorsal liner 1300 can separatefrom the ventral liner 1302 by curling away from the ventral liner 1302.The dorsal liner 1300 can separate from the ventral liner 1302 when thelocalization element 930 detaches from the pusher element 920. Forexample, because of the force acted upon the liner by the shape memoryof the localization element, the eyelet frame 1106 can separate thedorsal liner 1300 from the ventral liner 1302 at the liner distalsegment 1304 as the eyelet frame 1106 detaches or is physicallydisplaced from the delivery port 1118.

The dorsal liner 1300 can act as an additional safeguard against theinadvertent detachment of the localization element 930 from the pusherelement 920 when the localization element 930 is being translatedthrough the needle lumen 918. For example, the dorsal liner 1300 alongwith the port base 1124 of the pusher element 920 can act as anadditional layer of material to hold the eyelet frame 1106 within thedelivery port 1118 when the localization element 930 is within theneedle lumen 918 or in motion through the needle lumen 918.

The polymer liner 1200 including the dorsal liner 1300 and the ventralliner 1302 can be, attached, in part, to the pusher element 920. Forexample, the polymer liner 1200 can be attached to the pusher element920 by UV cured adhesives. The polymer liner 1200 can be mechanicallyfitted to the pusher element 920 by methods such as crimping within thepusher plug 926.

The dorsal liner 1300 can once again join with the ventral liner 1302 toradially ensheath or surround the pusher element 920 when the pusherelement 920 is translated in the second longitudinal direction 1006 backinto the needle lumen 918. For example, the dorsal liner 1300 can onceagain join with the ventral liner 1302 when the localization element930, along with the pusher element 920, is retracted back into theneedle lumen 918. Also, for example, the dorsal liner 1300 can againjoin with the ventral liner 1302 when the localization element 930 iscompletely deployed out of the delivery needle 906 and the empty pusherelement 920 is retracted back into the needle lumen 918.

FIGS. 14A and 14B illustrate that the delivery needle 906 can have abeveled distal end 1400 and a needle dimple 1402. The beveled distal end1400 can be defined by a rounded edge 1404 along a proximal rim 1406 ofthe beveled distal end 1400 and two lateral sharpened edges 1408converging into a needle tip 1410.

The rounded edge 1404 can be positioned proximal to the two lateralsharpened edges 1408 and the needle tip 1410. The two lateral sharpenededges 1408 and the needle tip 1410 can be configured to pierce throughthe dermis and into the underlying tissue of the patient. The proximalrim 1406 of the beveled distal end 1400 can be the portion of thebeveled distal end 1400 not included as part of the two lateralsharpened edges 1408 and the needle tip 1401. The rounded edge 1404 canbe a surface feature of the proximal rim 1406 formed by smoothing orrounding out the edges of the proximal rim 1406. The rounded edge 1404can have a radius. The rounded edge 1404 can reduce the mechanicaltrauma to the localization element 930 caused by an otherwisesharp-edged beveled distal end 1400.

The delivery needle 906 can have a needle dorsal side 1412 and a needleventral side 1414 opposite the needle dorsal side 1412. The needledimple 1402 can be a concavity, divot, or flattened region along theneedle dorsal side 1412. The needle dimple 1402 can be shaped as ahalf-ellipsoid. In other variations, the needle dimple 1402 can be ovalor oblong-shaped. The needle dimple 1402 can be proximal to the roundededge 1404 of the beveled distal end 1400.

FIG. 14C illustrates that the needle dimple 1402 can have a dimplelength 1418. For example, the dimple length 1418 can be betweenapproximately 0.5 mm and 1.5 mm.

FIG. 14D illustrates that the pusher element 920 covered by the polymerliner 1200 can translate longitudinally out of the beveled distal end1400 having the needle dimple 1402. The pusher element 920 can be anelongate half-cylinder having a hollow interior. The needle dimple 1402can allow the pusher element 920 to more easily exit the beveled distalend 1400 of the delivery needle 906.

FIG. 14E illustrates that the needle lumen 918 can have a lumen diameter1416. For example, the lumen diameter 1416 can be between approximately0.8 mm and 1.3 mm. FIG. 14E also illustrates that the needle dimple 1402can have a dimple width 1420. The dimple width 1420 can be betweenapproximately 0.5 mm and 1.1 mm. The dimple width 1420 can be less thanthe lumen diameter 1416 such that the pusher element 920 can translatepast the section of the delivery needle 906 defined by the needle dimple1402 without being obstructed by the needle dimple 1402.

When the dimple width 1420 is less than the lumen diameter 1416, thelateral sides of the pusher element 920 can be unobstructed by theneedle dimple 1402 as the pusher element 902 moves through the needlelumen 918. The needle dimple 1402 can allow the localization element 930to more easily exit the beveled distal end 1400 of the delivery needle906. For example, the needle dimple 1402 can reduce the likelihood ofthe eyelet frame 1106 from being inadvertently detached from thedelivery port 1118 when the localization element 930 is being deployedout of the delivery needle 906.

For example, the indentation of the needle dimple 1402 on the needlelumen 918 of the delivery needle 906 causes the localization element 930to be pushed away from the beveled distal end 1400 of the deliveryneedle 906 as it is retracted or advanced. This reduces the frictionand/or abrasion of the localization element 930 against the beveleddistal end 1400 of the delivery needle 906.

The needle dimple 1402 can allow the localization element 930 to beretracted into or deployed out of the beveled distal end 1400 of thedelivery needle 906 when at least part of the localization element 930has been deployed out of the delivery needle 906. As another example,the needle dimple 1402 can ensure the delivery port 1118 holds theeyelet frame 1106 by pushing the eyelet frame 1106 further into thedelivery port 1118 when the pusher element 920 is being retracted intothe needle lumen 918.

FIG. 14E also illustrates that the polymer liner 1200 can have a linerinner diameter 1422 and a liner outer diameter 1424. The liner innerdiameter 1422 can be between approximately 0.90 mm and 1.10 mm. Forexample, the liner inner diameter 1422 can be approximately 1.10 mm. Theliner outer diameter 1424 can be between approximately 1.00 mm and 1.20mm. For example, the liner outer diameter 1424 can be approximately 1.14mm.

FIG. 15A illustrates that the tracking wire 932 can be coupled to thelocalization element 930 at the locator proximal end 1100. For example,the tracking wire 932 can be looped around the eyelet frame 1106 of thelocalization element 930. As shown in FIG. 15A, the localization element930 can have a substantially circular deployed configuration 942. Thedeployed configuration 942 can be a predetermined shape or configurationof the localization element 930. For example, the deployed configuration942 can be a shape memory configuration obtained by heat setting thelocalization element 930 during its manufacturing process. Thelocalization element 930 can automatically transform into its deployedconfiguration 942 when deployed or detached from the rest of the tissuelocalization device 900.

FIG. 15B illustrates that the localization element 930 can have alocator length 1500. For example, when the localization element 930 isformed into a substantially circular deployed configuration 942, thelocator length 1500 can be a perimeter length. FIG. 15B illustrates thatthe tracking wire 932 can be coupled to the localization element 930 ata midpoint 1502 along the locator length 1500. For example, thelocalization element 930 can have an aperture or notch defined at themidpoint 1502 and the tracking wire 932 can be looped through theaperture or notch and tied to the localization element 930 at themidpoint 1502.

The tracking wire 932 can be coupled to the localization element 930 ata point in between the midpoint 1502 and the locator proximal end 1100or in between the midpoint 1502 and the locator distal end 1102. Thetracking wire 932 can be coupled to the midpoint 1502 or another pointalong the length of the localization element 930 other than the locatorproximal end 1100 to prevent the tracking wire 932 from inadvertentlydisplacing or retracting the localization element 930 when thelocalization element 930 is deployed within the tissue of a patient. Forexample, the tracking wire 932 can inadvertently displace or retract thelocalization element 930 when a user pulls on the tracking wire 932 orthe patient moves after the localization element 930 is deployed withinthe tissue of the patient.

FIGS. 15C and 15D illustrate that the localization element 930 having asickle or falciform-shaped deployed configuration 942. The sickle orfalciform shape can be a partial circular shape or crescent shape. Asshown in FIG. 15C, the tracking wire 932 can be coupled to the sickle orfalciform-shaped localization element 930 at the locator proximal end1100.

FIG. 15E illustrates that the tracking wire 932 can be coupled to thelocalization element 930 having the sickle or falciform-shaped deployedconfiguration 942 at a midpoint 1502 along the curved locator length1500 of the localization element 930. The different deployed shapes ofthe localization element 930 can allow the tissue localization device900 to localize or demarcate tissue masses of different sizes andshapes.

FIG. 15F illustrates that the tracking wire 932 can be coupled to thelocalization element 930 at an attachment point 1504 along the locatorlength 1500 in between the midpoint 1502 and the locator proximal end1100. For example, the attachment point 1504 can be located at a pointone-quarter the locator length 1500. The localization element 930 canhave an aperture or notch defined at the attachment point 1504 and thetracking wire 932 can be looped through the aperture or notch and tiedto the localization element 930 at the attachment point 1504.

FIG. 16 illustrates that the localization element 930 can have acurvature plane 1600 when in the deployed configuration 942. Thecurvature plane 1600 can be a two dimensional plane used to orient thelocalization element 930. For example, in the variations of thelocalization element 930 shown in FIGS. 11A to 11F, the entirelocalization element 930 can be curved substantially in alignment withthe curvature plane 1600. FIG. 16 illustrates that at least part of thelocalization element 930 can be curved in alignment with the curvatureplane 1600 and another part of the localization element 930 can becurved or otherwise oriented out of the curvature plane 1600.

For example, the locator proximal end 1100 can be curved in alignmentwith the curvature plane 1600 and the locator distal end 1102 can becurved out of the curvature plane 1600. As shown in FIG. 16, thelocalization element 930 can have a full or partial helical shape whenin the deployed configuration 942. A part of the localization element930 can curve out of the curvature plane 1600 to localize or demarcate asuspect tissue mass in the patient's body in three-dimensions.

FIG. 17 illustrates that the localization element 930 can have abranched distal segment 1700. As shown in FIG. 17, the branched distalsegment 1700 can be an instance of the locator distal end 1102 havingtwo or more sharpened locator tips 1104. For example, when the brancheddistal segment 1700 has two sharpened locator tips 1104, the twosharpened locator tips 1104 can diverge at an angle away from oneanother. The branched distal segment 1700 of the localization element930 can allow the localization element 930 to more securely anchor intothe tissue of the patient, and also can more fully delineate the tissuesite in three dimensions.

FIG. 18A illustrates that the localization element 930 deployed into thetissue 1800 of a patient can encircle or radially surround at least partof a suspect tissue mass 1802. For example, the tissue 1800 can includebreast tissue or lung tissue. The suspect tissue mass 1802 can include atumor or other cancerous cells, necrotic tissue, lymph nodes,scar-tissue, target tissue, fibro adenoma, calcifications, otherwisediseased tissue, or combinations thereof.

FIG. 18A illustrates that the localization element 930 in the deployedconfiguration 942 can be curved or curled in alignment with a curvatureplane 1600. The localization element 930 can encircle or radiallysurround at least part of the suspect tissue mass 1802 when thecurvature plane 1600 intersects at least part of the suspect tissue mass1802. The deployed localization element 930 can serve as a boundary orguide for identifying and demarcating the location or boundary (e.g. theposterior margin) of the suspect tissue mass 1802 for further analysisor excision.

FIGS. 18B-18E illustrate that the localization element 930 can bedeployed adjacent to or abutting the suspect tissue mass 1802. Forexample, the localization element 930 can be deployed above or proximalto the suspect tissue mass 1802 such that the localization element 930forms a type of halo adjacent the suspect tissue mass 1802. Thisdeployment can be referred to as a halo deployment. The localizationelement 930 can be deployed at one or more locations adjacent to orabutting the suspect tissue mass 1802 such that the curvature plane 1600formed by the localization element 930 does not intersect at least aportion of the suspect tissue mass 1802. By deploying the localizationelement 930 above or away from the suspect tissue mass 1802, the usercan ensure that the localization element 930 does not puncture, pierce,or otherwise disturb the suspect tissue mass 1802 or other tissuestructures nearby (e.g., nerves, blood vessels, etc.).

FIGS. 18A, 18B, and 18D illustrate that at least a segment of thetracking wire 932 can extend out of the tissue 1800 of the patient whilethe wire distal end 936 coupled to the localization element 930 isdeployed within the tissue 1800 of the patient. The tracking wire 932can serve as a path or trail informing a surgeon of the path taken bythe delivery needle 906 into the patient's tissue 1800. The trackingwire 932 may also serve as an intraoperative guide to the location ofthe localization element 930.

A method of locating the suspect tissue mass 1802 using the deployedlocalization element 930 and the tracking wire 932 can involveperiodically pulling on the segment of the tracking wire 932 extendingoutside of the tissue 1800 of the patient. For example, a surgeonresponsible for excising a suspect tissue mass 1802 can pull or tug onthe segment of the tracking wire extending outside the tissue 1800 ofthe patient. The method can further involve palpating or feeling, withat least one finger of a user, an outer tissue layer (e.g., a skin ordermis) above or proximal to a target tissue site while pulling on thesegment of the tracking wire 932 extending outside the tissue 1800 ofthe patient. The method can also involve locating the suspect tissuemass 1802 within the tissue 1800 of the patient based on a tensionexhibited by the tracking wire 932 being pulled and the movement felt bythe finger of the user on the outside tissue layer.

If electrocautery is used during surgical dissection, several attributesof the localization element 930 can reduce the risk of damage to thelocalization element 930 and tracking wire 932 from inadvertent arcingof electrocautery during surgical dissection. Inadvertent passage ofcurrent to the tracking wire 932 can be reduced because the polymerjacketing 1132 of the tracking wire serves as an electrical insulator.Also, because of the ribbon-like and hence relatively large surface areathe localization element 930, it may be less prone to inadvertentelectrocautery damage than a localization wire with a smaller surfacearea, as the larger surface area is inherently more electricallydissipative.

FIGS. 19A-19C illustrate that the tracking wire 932 can be flexibleenough to be easily wound into a coiled segment 1900. The tracking wire932 is extremely flexible, having a flexibility comparable to surgicalsuture or household sewing thread. For example, the segment of thetracking wire 932 extending outside the tissue 1800 of the patient (seeFIG. 19B) can be easily wound into the coiled segment 1900 and can betaped (e.g., with Tegaderm™ or other biocompatible adhesives, bandages,or dressings) to the skin of the patient (see FIG. 19C). Coiling thetracking wire 932 can reduce the length of the excess segment of thetracking wire 932 extending out of the patient's tissue and can ensurethat the excess segment of the tracking wire 932 will not interfere withthe patient while wearing normal clothing or dressing or will notprevent the patient from sleeping normally.

The secure retention properties of the localization element 932 withinthe tissue site, combined with the suture-like flexibility of thetracking wire can enable a breast patient to go home after placement ofthe localization element. Prior to this device, current localizationwires are too prone to movement and are too stiff to allow the patientto return to home with localization wire in place. This attribute isimportant because this enables the localization procedure to bede-coupled from the surgical tissue removal procedure (e.g. lumpectomy).This has valuable clinical scheduling implications because with the useof this device, the surgeon no longer has to rely on the localizationelement to be placed the day of the scheduled surgical excision (e.g.lumpectomy), eliminating delays and operating room schedulinguncertainties, which can be costly to the healthcare system.

FIG. 20A illustrates that the tracking wire 932 can be fabricated from acable that is composed of a number of filaments 2000. For example, thecable of the tracking wire 932 can comprise or be composed of amulti-filament (e.g., 19-filament) wire, where each filament is composedof stainless steel, tungsten, or other material. In other variations,the tracking wire 932 can comprise or be composed of between seven and31 filaments 2000. Each of the filaments 2000 can have a filamentdiameter. In some variations, the filament diameter can be betweenapproximately 0.025 mm and 0.035 mm. For example, the filament diametercan be approximately 0.030 mm. The tracking wire 132 can also have awire diameter, the wire diameter can be between approximately 0.150 mmand 0.155 mm. For example, the wire diameter can be approximately 0.152mm. The cable can alternatively be comprised of polymer fibers which canhave an even greater strand count (e.g., up to 100 polymer strands), andcan have a different diameter. For example, the wire diameter canalternatively be between approximately 0.125 mm and 0.255 mm.

FIG. 20B illustrates that a distal end of the tracking wire 932 can havea welded tip 2002 to capture and join together the plurality of filamentends. FIG. 20C illustrates that a polymer jacketing 1132 can ensheath orotherwise surround the attachment site 1130 of the tracking wire 932.The polymer jacketing 1132 can be made of heat-shrinkable material andcan thus conform more closely to the underlying cables of the trackingwire 932. FIG. 20C illustrates a cross-section of the tracking wire 932prior to the polymer jacketing 1132 undergoing the heat-shrinkingprocess, and FIG. 20D is a cross-section illustrating the polymerjacketing 1132 conforming to the tracking wire 932 after undergoingheat-shrinking. The attachment site 1130 can be a site or segment alongthe tracking wire 923 where one segment of the tracking wire 932 isattached to another segment of the tracking wire 932. For example, thewire distal end 936 can be threaded through the aperture 1108 within theeyelet frame 1106 and looped back to align with a more proximal segmentof the tracking wire 932. The wire distal end 936 can then be welded tothe more proximal segment of the tracking wire 932 and the weld site canbe referred to as the attachment site 1130.

The polymer jacketing 1132 may surround a portion of the tracking wire932 in proximity to the attachment site 1130 between the tracking wire932 and the localization element 930, or the polymer jacketing 1132 mayextend a length of the tracking wire 932. The polymer jacketing 1132 canalso be used to identify lengths of the tracking wire 932. For example,an additional layer of the polymer jacketing 1132 can be disposed aroundan approximately 3 cm long portion of the tracking wire 932 at a distalend of the wire 932. The additional layer of jacketing 1132 can changethe feel of the wire 932 to a surgeon using the tracking wire 932 tolocate a target tissue site, identifying to the surgeon when he/she isapproaching the distal end of the tracking wire 932. Additional layersof the jacketing 1132 may alternatively be disposed at other locationsalong the tracking wire 932, such as every 2 cm along its length.Alternatively, one or more metallic ferrules (e.g. stainless steel,tantalum) may be placed at one or more locations along the length of thetracking wire 932 (e.g. beneath the polymer jacketing) to signifyvarious levels of proximity to the localization element 930. Other depthmarking methods may include printing or the use of different coloredpolymer segments.

The polymer jacketing 1132 can be composed of one or more polymers, suchas polyolefin, polyvinyl chloride (PVC), or a thermoplastic elastomer(e.g., PEBAX″). By enclosing at least a portion of the tracking wire 932in a polymer jacketing 1132, wear and risk of damage to the trackingwire 932 may be reduced. In addition, the polymer jacketing 1132 mayalso reduce snagging or fraying of the tracking wire 932.

FIG. 21 illustrates a method 2100 of operating the tissue localizationdevice 900. The method 2100 can involve removing the tissue localizationdevice 900 from a sterile package in operation 2102. The method 2100 canalso involve removing a needle protector covering the delivery needle906 in operation 2104. The method 2100 can further involve holding thehandle 902 of the tissue localization device 900 with one hand andadvancing the delivery needle 906, under ultrasonic or radiologicguidance, into the tissue of the patient until the distal end 1400 ofthe delivery needle 906 is adjacent to a suspect tissue mass (or othertarget tissue site) 1802 in operation 2106. The method 2100 can furtherinvolve translating or pushing the delivery control 904 of the tissuelocalization device 900 in a first longitudinal direction 1004 using atleast one finger of the same hand holding the handle 902 in operation2108.

The method 2100 can further involve translating the localization element930 of the tissue localization device 900 out of the delivery needle 906in response to the translation of the delivery control 904 in operation2110. The localization element 930 can be deployed out of the distal end1400 of the delivery needle 906 when a delivery port 1118 of a pusherelement 920 holding the localization element 930 is advanced out of theneedle lumen 918. If the localization element 930 is not deployed in adesired path, the localization element 930 can be retracted into theneedle lumen after at least part of the localization element 930 isdeployed out of the delivery needle 906. The delivery needle 906 cansubsequently be repositioned. For example, the delivery needle 906 canbe rotated about a longitudinal axis of the delivery needle 906 (e.g.,to achieve a desired deployment path for the localization element 930),and the localization element 930 can be redeployed out of the deliveryneedle 906 into the tissue.

The method 2100 can further involve surrounding, encircling, orotherwise identifying the suspect tissue mass 1802 using the deployedlocalization element 930 in operation 2112. The localization element 930can form into the deployed configuration 942 around the suspect tissuemass 1802 or above the suspect tissue mass 1802. The localizationelement 930 can automatically disengage or detach from the pusherelement 920 when the delivery port 1118 of the pusher element 920 isadvanced out of the needle lumen 918.

The method 2100 can further involve retracting the beveled distal end1400 of the delivery needle 906 away from the suspect tissue mass 1802and exposing the tracking wire 932 coupled to the localization element930 in operation 2114. The method 2100 can also involve coiling and/orcutting the segment of the tracking wire 932 extending out of the tissueof the patient and securing (e.g., using Tegaderm™ or anotherbiocompatible adhesive or dressing) the coiled or cut segment of thetracking wire 932 directly or indirectly to the skin or patient dressingof the patient in operation 2116. By doing so, the tracking wire 932extending out of the body of the patient can be secured closer to thebody of the patient (e.g., flush with the skin surface) such that thetracking wire 932 is not inadvertently pulled or displaced. At thispoint, the patient can be sent home from the procedure and asked toreturn the following day to surgically excise the localized tissue mass1802 from the patient, or the suspect tissue mass 1802 can be excisedthe same day. The same facility which placed the localization element930 into the body of the patient can perform the excision procedure suchas the lumpectomy.

FIG. 22 illustrates a method 2200 for using a tissue localization deviceto localize tissue. The method 2200 is described with respect to FIGS.23A-G.

The method 2200 can include holding the tissue localization device inone hand while holding an ultrasound transducer in another hand (2202).For example, FIG. 23A shows a user holding the tissue localizationdevice 900 in a first (e.g., right) hand 2304 while holding anultrasound transducer 2302 in a second (e.g., left) hand 2306. Themethod 2200 is described with respect to use of the tissue localizationdevice 900, the user may alternatively hold the tissue localizationdevice 100 in the first hand 2304. The tissue localization device 900and ultrasound transducer 2302 can each be operable with a single handof the user, and sized to fit within a single hand of the user. Thus,the user can concurrently operate both the tissue localization device900 and the ultrasound transducer 2302.

The method 2200 can include advancing, using one hand, a needle tip 2312of the delivery needle 906 into a tissue 2300 at an offset from a targettissue site 2318 in step 2204. The target tissue site can include asuspect tissue mass such as a tumor or lesion, a volume of tissueimmediately surrounding a suspect tissue mass, or any other volume ofthe tissue 2300. To reduce a distance the needle 906 travels through thetissue 2300, the needle 906 can be advanced at an angle 2320 from a baseof the tissue 2300. For example, if the tissue 2300 is breast tissue ofa patient, the needle 906 can be advanced at an angle 2320 from a chestplane of the patient. The angle 2320 may depend on a size of the tissue2300, a size of the localization element 930, a size of the targettissue site 2318, orientation of the tissue localization device 900 withrespect to the tissue, or other factors. For example, the angle 2320 issmall enough that the localization element 930 when deployed will notpass through a surface of the tissue 2300, but large enough to reduce,where possible, the distance the needle 906 travels through the tissue2300.

The needle tip 2312 can be advanced into the tissue 2300 untilpositioned in a plane intersecting the target tissue site, a planeproximal to the target tissue site, or a plane distal to the targettissue site, while offset from the target tissue site 2318. The offsetcan be a threshold distance from an edge of the target tissue site suchthat the localization element 930 when deployed does not intersect thetarget tissue site. As shown for example in FIG. 23B, the needle tip2312 is offset from the target tissue site 2318 by a distance 2314. Theoffset can be toward a side of the target tissue site 2318 distal to theuser of the tissue localization device 900. For example, if the patientis lying on her back while the method 2200 is performed, the needle tip2312 can be offset toward the patient's dorsal side relative to thetarget tissue site 2318.

The offset from the target tissue site can be limited based on adiameter of the localization element 930 when deployed and a size of thetarget tissue site 2318. For example, the distance 2314 is less than adifference between a diameter of the localization element and a diameterof the target tissue site, enabling the localization element 930 whendeployed to radially surround at least part of the target tissue sitewithout intersecting the target tissue site. Alternatively, the needletip 2312 may be offset from the target tissue site 2318 in a planeproximal or distal to the target tissue site 2318. For example, theneedle tip 2312 may be offset proximal to the target tissue site 2318such that the localization element is deployed as illustrated in FIG.18B, in which a curvature plane formed by the deployed localizationdevice 930 does not intersect the target tissue site 2318. The user canuse the slidable delivery control 904 to determine an expected directionof curvature of the localization element 930. For example, thelocalization element 930 may curve toward a side of the tissuelocalization device 900 on which the slidable delivery control 904 isdisposed. The slidable delivery control 904 can alternatively identifythe expected direction of curvature of the localization element 930 inother ways.

The method 2200 can further include positioning, using another hand, theultrasound transducer 2302 proximal to the target tissue site on asurface of the tissue (2206). For example, referring again to FIG. 23B,the ultrasound transducer 2302 is positioned on a surface 2316 of thetissue 2300, proximal to the target tissue site 2318. The ultrasoundtransducer 2302 can be positioned on the tissue surface 2316 while thetissue localization device 900 is inserted into the tissue 2300.

The method 2200 can further include deploying the localization element930 out of the delivery needle 906 into the tissue (2208). Thelocalization element 930 can be deployed by pushing a slidable deliverycontrol 904 in a first longitudinal direction along the tissuelocalization device 900. For example, in FIG. 23C, the slidable deliverycontrol 904 is pushed in a first longitudinal direction 2320 along thetissue localization device 900 (e.g., toward a distal end of the tissuelocalization device 900) to deploy the localization element 930 from thedelivery needle 906. In other variations, the localization element 930can be deployed in other ways, such as by turning a knob in a firstrotational direction. While the localization element 930 is beingdeployed, the ultrasound transducer 2302 can be used to view a positionof the localization device 930 in the tissue and verify that thelocalization device 930 is deployed to surround or otherwise identifythe target tissue site 2318 without intersecting the target tissue site.

The method 2200 can further include moving the ultrasound transducer2302 on the tissue surface while deploying the localization element 930in step 2210. The ultrasound transducer 2302 can be moved on the tissuesurface 2316 in a number of different ways, including translation acrossthe surface (e.g., while remaining perpendicular to the surface) androtation around axes of the ultrasound transducer (e.g., yaw, pitch, orroll rotation). FIG. 23D illustrates an example of the ultrasoundtransducer 2302 moved on the surface 2316 of the tissue 2300 in a pitchrotation 2322 around a transverse axis of the ultrasound transducer2302, concurrently with the deployment of the localization element 930.FIG. 23E is a schematic illustrating a side view of the pitch rotation2322 shown in FIG. 23D. By moving the ultrasound transducer 2302 in thepitch rotation 2322, the position of the localization element 930 can bebetter visualized, for example if the localization element 930 passesout of an image window detectable by the ultrasound transducer 2302, orif the target tissue site 2318 partially or fully obscures thelocalization element 930 from detection by the original position of theultrasound transducer 2302. Other movements of the ultrasound transducer2302 may similarly improve visualization of the localization element 930as the element is deployed.

The localization element 930 can continue to be deployed out of thedelivery needle 906, while the ultrasound transducer 2302 is moved asdesired, until the localization element 930 has been completely deployedfrom the delivery needle 906. FIG. 23F illustrates an example of thelocalization element 930 deployed to at least partially surround thetarget tissue site 2318. During deployment of the localization element930, the localization element 930 can be retracted into the deliveryneedle 906 if, for example, the user desires to change the position ofthe localization element 930 in the tissue. The localization element 930can be retracted by moving the slidable delivery control 904 in a secondlongitudinal direction opposite the first longitudinal direction 2320(e.g., toward a proximal end of the tissue localization device 900). Thelocalization element 930 may in other variations be retracted by othermechanisms, such as by turning a knob in a second rotational directionopposite the first rotational direction. Retracting the localizationelement 930 can allow the user to adjust a starting position ordirection of curvature of the localization element 930 in the tissue2300. For example, if the user determines the localization element 930is deploying along a curvature path different from a desired path, theuser can retract the localization element 930 into the delivery needle906, rotate the tissue localization device 900 around a longitudinalaxis, and begin redeploying the localization element 930. The user canalternatively change a position of the needle tip in the tissue 2300.When fully deployed from the delivery needle 906, the localizationelement 930 may automatically disengage or detach from the tissuelocalization device 900.

The method 2200 can further include, in step 2212, removing the deliveryneedle 906 from the tissue 2300 and exposing the tracking wire 932coupled to the localization element 930. FIG. 23G illustrates thetracking wire 932 extending out of the tissue 2300 after the deliveryneedle 906 is removed from the tissue 2300. The tracking wire 932 can becoiled or cut and secured to the body of the patient.

FIGS. 24A-G illustrate several variations of the localization element930. As illustrated in FIG. 24A, the localization element 930 may have asurface 2410 that is substantially smooth. For example, the surface 2410may be polished by electrochemical, electrolytic, or mechanicalpolishing. In other variations, the localization element surface 2410may include an echogenic surface treatment, or a surface roughness toincrease the echogenicity of the localization element 930 for improvedvisualization under ultrasound. FIG. 24B illustrates a surface roughness2412 achieved by abrasive blasting of the localization element 930, suchas sandblasting or bead blasting. FIGS. 24C-F illustrate various examplepatterns 2414 cut into the localization element surface 2410 by lasercutting, laser etching, or other surface cutting mechanism. FIGS. 24C-Eillustrate that the patterns 2414 can be cut into an exterior surface ofthe localization element 930, while FIG. 24F illustrates that a patterncan be cut into a side of the localization element 930. Patterns orother echogenic surface treatments may alternatively be applied to aninterior surface of the localization element 930, or can be applied to acombination of the exterior, side edge, and interior surfaces of thelocalization element 930.

Other patterns than those shown in FIGS. 24C-E may alternatively be cutinto the localization element surface 2410, and random lines, dots, orother shapes can be used instead of patterned cuts. For example, a gridof dots may alternatively be cut into the localization element surface2410. The patterns or shapes may be cut to a depth between 0% andapproximately 25% of a thickness of the localization element 930. Eachcut into the localization element surface 2410 can be at least as deepinto the surface 2410 as it is wide, or can have a depth that is greaterthan its width. The width of each cut can be, for example, approximately0.001 to 0.006 inches. The patterns 2414 or random lines, dots, or otherstructures may alternatively protrude from the localization elementsurface 2410.

As illustrated for example in FIG. 24G, one or more holes 2416 can becreated through the localization element 930 (e.g., radially from theinterior surface to the exterior surface of the localization element930). The one or more holes 2416 can be created (e.g. drilled or lasercut) near a distal tip of the localization element 930, as illustratedin the example of FIG. 24G, or can be created at other locations alongthe localization element 930.

As described above with respect to FIGS. 11A-B, the tissue localizationdevice 900 can include a pusher element 920 that, in addition todeploying the localization element 930 from the tissue localizationdevice 900, can retract the localization element 930 into the tissuelocalization device 900. FIGS. 25A-B illustrate that the tissuelocalization device 900 can include a pusher element 2520 configured todeploy the localization element 930 from the tissue localization device900 but not retract the localization element 930. FIG. 25C illustrates across-section of a non-retractable pusher element 2520 shown in FIGS.25A and 25B while inside the delivery needle 906. As shown in FIG. 25C,the distal terminal end of the pusher element 2520 can abut, contact andpush against a proximal terminal end 2530 of the localization element930. Sliding the slidable delivery control 904 toward a distal end ofthe tissue localization device 900 (e.g., toward the left side of FIG.25C) can cause the pusher element 2520 to push on the proximal end 2530of the localization element 930, thereby deploying the localizationelement 930 from the delivery needle 906. However, sliding the slidabledelivery control 904 toward a proximal end of the tissue localizationdevice 900 (e.g., toward the right side of FIG. 25C) can retract thepusher element 2520 away from the proximal end 2530 of the localizationelement 930 until the pusher element 2520 is no longer in contact withthe localization element 930, without applying force to the localizationelement 930 sufficient to retract the localization element 930 into thetissue localization device 900. The shape of the face of the distalterminal end of the pusher element 2520 can be the inverse of the shapeof the face of the proximal terminal end 2530 of the localizationelement 930. For example, the respective faces can be perpendicular tothe respective longitudinal axes, as shown in FIG. 25C.

FIG. 26 illustrates that the localization element 930 can include one ormore barbs 2610 protruding from the localization element 930. The barbs2610 can limit retractibility of the localization element 930, or canhelp secure the localization element 930 in tissue. The barbs 2610 canprotrude from some portion or an entire length of the localizationelement 930. For example, the localization element 930 can include barbs2610 near a proximal end 2530 of the localization element 930, within anangle 2612 of the proximal end 2530. The angle 2612 may be anypercentage of the deployed configuration of the localization element930. The angle 2612 can be between approximately 10% and 25% of thecircumference of the deployed configuration of the localization element930. Alternatively, the angle 2612 can be up to 100% of the deployedconfiguration of the localization element 930. Although FIG. 26illustrates the barbs 2610 protruding from an exterior surface of thelocalization element 930, the barbs can additionally or alternativelyprotrude from a side edge or interior surface of the localizationelement 930.

The barbs 2610 shown in FIG. 26 can provide resistance againstretraction of the localization element 930 after one or more of thebarbs 2610 have entered the tissue of a patient. For example, thelocalization element 930 may be retractable while a distal portion isdeployed into the tissue of a patient and the proximal end remainsinside the delivery needle 906 of the tissue localization device 900.However, the localization element 930 may not be retractable, or mayhave limited retractability, after a portion of the localization element930 including a barb 2610 has been deployed into the tissue.

As shown in FIG. 12, the tissue localization device 900 can include apolymer liner 1200 encasing or surrounding at least a portion of thepusher element 920. FIG. 27 illustrates that the tissue localizationdevice 900 can include a stainless steel liner 2700. Other aspects ofthe tissue localization device 900 can be similar to aspects describedwith respect to FIGS. 9 and 12. The stainless steel liner 2700 can beradially between at least part of the localization element 930 and aneedle lumen of the delivery needle 906. For example, the stainlesssteel liner 2700 can be a substantially cylindrical tube having a hollowlumen, and can radially surround at least a portion of the localizationelement 930. The stainless steel liner 2700 optionally can also radiallysurround at least a portion of the pusher element 920. The deliveryneedle 906 of the tissue localization device 900 in turn can radially atleast part of the stainless steel liner 2700 and the pusher element 920.

The stainless steel liner 2700 can completely encircle or radiallysurround the pusher element 920 such that no contact is made between theexternal surface of the pusher element 920 and the delivery needle 906as the pusher element 920 is translated longitudinally through thedelivery needle 906. In another variation, the liner 2700 can cover adorsal side of the pusher element 920 or localization element 930 tolimit the pusher dorsal side or localization element dorsal side fromcontacting an inner dorsal surface of the delivery needle 906 as thepusher element 920 and localization element 930 are translatedlongitudinally. The liner 2700 can cover a ventral side of the pusherelement 920 or localization element 930 to limit the pusher ventral sideor localization element ventral side from contacting an inner ventralsurface of the delivery needle 906 as the pusher element 920 andlocalization element 930 are translated longitudinally.

The stainless steel liner 2700 can be slidably translatable within thedelivery needle 906. The stainless steel liner 2700 and pusher element920 can be coupled to the slidable delivery control 904, such thattranslation of the slidable delivery control 904 in a first longitudinaldirection (e.g., toward a distal end of the delivery needle 906) causesthe stainless steel liner 2700 and localization element 930 to translatetoward the distal end of the delivery needle 906. The liner 2700 canaccommodate release of the localization element 930 from the pusherelement 920. For example, the localization element 930 can be releasablefrom the liner when a distal end of the pusher element 920 is translatedlongitudinally beyond the liner. The liner 2700 can have a wallthickness of approximately 0.002 to 0.004 inches.

The tissue localization device 900 can further include a spring 2710.The spring 2710 can be coupled to a proximal end of the stainless steelliner 2700, and a distal end 2712 of the spring 2710 can push or pullthe liner 2700 to slide longitudinally through the delivery needle 906in response to longitudinal translation of the slidable delivery control904. The spring 2710 is configured to compress in response to distaltranslation of the slidable delivery control 904 when a distal end 2712of the spring 2710 contacts a distal end 2714 of the tissue localizationdevice handle 902. While the spring 2710 compresses, the spring 2710stops translation of the stainless steel liner 2700 and enables thepusher element 906 to translate relative to the liner 2700. Thus, whilethe spring 2710 is uncompressed, the pusher element 920 and stainlesssteel liner 2700 can be configured to translate together toward a distalend of the delivery needle 906 in response to a distal translation ofthe slidable delivery control 904. However, while the spring 2710 is atleast partially compressed, the pusher element 920 can be configured totranslate toward the distal end of the delivery needle 906, relative tothe liner 2700, in response to the distal translation of the slidabledelivery control 904.

FIG. 28A illustrates an example of the stainless steel liner 2700 andspring 2710 prior to compression of the spring 2710, while FIG. 28Billustrates partial compression of the spring 2710 allowing translationof the pusher element 920 relative to the liner 2700. As shown in FIG.28A, the spring 2710 may be short enough to not contact the handledistal end 2714 through a portion of a range of motion of the slidabledelivery control 904. Sliding the slidable delivery control 904 duringthat portion of the range of motion may therefore also move the spring2710 and liner 2700 through the handle 902 and needle 906. FIG. 28Billustrates the distal end 2712 of the spring 2710 in contact with thedistal end 2714 of the tissue localization device handle 902. The handledistal end 2714 can have a smaller diameter than the spring 2710 to stoptranslation of the spring distal end 2712. Alternatively, the handle 902may include a block or other mechanism at the handle distal end 2714 toprevent translation of the spring distal end 2712 toward a distal end ofthe tissue localization device 900. When the spring distal end 2712contacts the handle distal end 2714, further distal translation of theslidable delivery control 904 can compress the spring 2710.

Because the stainless steel liner 2700 is coupled to the spring 2710,the liner 2700 may not translate through the delivery needle 906 whilethe spring 2710 is at least partially compressed. However, distaltranslation of the slidable delivery control 904 may continue to pushthe pusher element 920 toward the distal end of the delivery needle 906,even after the spring 2710 has started to compress. Accordingly, thepusher element 920 can be translated relative to the liner 2700 whilethe spring 2710 is at least partially compressed. As shown in FIG. 28B,a portion of the pusher element 920 is pushed out of the liner 2700,exposing a distal end 2716 of the pusher element 920. For example, therelative translation of the pusher element 920 with respect to the liner2700 can expose a connection point 2802 at which the localizationelement 930 (not shown in FIG. 28B) can connect to the pusher element920. Exposing the connection point 2802 enables the localization element930 to release from the pusher element 920.

The liner 2700 can enclose at least a connection point 2802 between thepusher element 920 and the localization element 930. Enclosing theconnection point 2802 and at least part of the localization element 930within the liner 2700 can reduce friction between the connection point2802, localization element 930, and delivery needle 906. In particular,spring force in the localization element 930, which can be configured todeploy from the delivery needle 906 in a curved configuration, can pushthe proximal end of the localization element 930 against an innersurface of the delivery needle 906. The connection point 2802 may haveirregularly shaped surfaces that can further increase friction againstthe delivery needle 906. By enclosing at least the proximal end of thelocalization element 930 and the connection point 2802 within thestainless steel liner 2700, the spring force can push the proximal endagainst the liner 2700 rather than the inner surface of the deliveryneedle 906. Accordingly, the inner surface of the delivery needle 906can be protected from potential damage from the localization element 930and pusher element 920 sliding against the inner surface of the deliveryneedle 906, and friction resisting the deployment of the localizationelement 930 can be reduced. The liner 2700 may enclose more of thelocalization element 930 than the proximal end; for example, the liner2700 may enclose up to the entire localization element 930 beforedeployment.

A length of the spring 2710 is based on an amount of the localizationelement 930 enclosed in the stainless steel liner 2700. In particular,the difference between the compressed and uncompressed lengths of thespring 2710 can be at least the length of the localization element 930and connection point 2802 with the pusher element 920 that are enclosedwithin the liner 2700. Alternatively, in variations using the pusherelement 2520 described with respect to FIGS. 25A-C instead of the pusherelement 920, the difference between the compressed and uncompressedlengths of the spring may be more or less than the length of thelocalization element 930 enclosed in the liner 2700.

The tissue localization device 900 can include a retraction lock thatprevents or limits retraction of the pusher element 920 into thestainless steel liner 2700 after the localization element 930 has beenfully deployed. Limiting retraction of the pusher element 920 canimprove the safety of the tissue localization device 900 afterdeployment of the localization element 930. For example, tissue of thepatient may be pinched between the pusher element 920 and the liner 2700or delivery needle 906 as the pusher element 920 is retracted;preventing or limiting the retraction can reduce the likelihood ofpinching the tissue of the patient. Furthermore, since the pusherelement 920 may extend beyond an end of the delivery needle 906 aftercomplete deployment of the localization element 930, as shown forexample in FIG. 28B, the pusher element 920 can additionally oralternatively shield the tip of the delivery needle 906 to reduce alikelihood of the user of the tissue localization device 900 injuringthemselves or others with the exposed sharp needle tip after the tip iswithdrawn from the tissue.

FIGS. 29A-J illustrate that the retraction lock can limit retraction ofthe pusher element 920. FIGS. 29A and 29B are top-view cross-sections ofthe tissue localization device handle 902 and the pusher plug 926. Asdescribed above with respect to FIG. 9, the pusher plug 926 can becoupled to the slidable delivery control 904 and pusher element 920, andcan transfer longitudinal motion of the slidable delivery control 904 tothe pusher element 920. Referring to the example of FIGS. 29A-B, thepusher plug 926 can include one or more spring-loaded pins 2912 that canbe compressed inside the lumen of the handle 902 (as shown in FIG. 29A)and, as shown in FIG. 29B, can translate or pop into holes 2910 when thepusher plug 926 reaches a designated position in the handle 902. Forexample, the holes 2910 can be placed such that the pins 2912 can popinto the holes 2910 when the localization element 930 is fully deployedand has separated from the pusher element 920. The holes 2910 can beplaced such that the pins 2912 pop into the holes when the slidabledelivery control 904 is pushed beyond the point at which thelocalization element 930 separates from the pusher element 920. Thespring-loaded pins 2912 may have limited lateral movement, limiting alongitudinal distance the slidable delivery control 904 can be movedafter the pins 2912 have locked into the holes 2910. The spring-loadedpins 2912 may be compressible to slide back into the handle 902 lumenafter locking into the holes 2910, permitting translation of theslidable delivery control and retraction of the pusher element 920.

FIGS. 29C-F are top-view cross-sections of another example of aretraction lock. In the example of FIGS. 29C-F, one or more teeth 2916can be coupled to the pusher plug 926 and one or more locks 2914 can bedisposed on an inner surface of the handle 902 lumen. The locks 2914 canbe spring-loaded or hinged to permit free movement of the teeth 2916 andpusher plug 926 in a distal direction (e.g., toward the left of FIG.29C). FIGS. 29D and E illustrate progressive rotation of the locks 2914to permit movement of the teeth 2916 in the distal direction. After theteeth 2916 have moved to a distal side of the teeth 2916, as shown inFIG. 29F, the locks 2914 may rotate back to an initial position toprevent or limit movement of the pusher plug 926 toward the proximal endof the tissue localization device 900 (e.g., toward the right of FIG.29D). The locks 2914 may be positioned in the handle 902 such that theteeth 2916 are distal to the locks 2914 at or beyond the point thelocalization element 930 is fully deployed. Alternative variations ofthe teeth 2916 can lock into holes when the pusher plug 926 istranslated forward to a designated position in the tissue localizationdevice handle 902. The one or more teeth 2916 when locked in the holescan limit proximal translation of the slidable delivery control 904.

FIGS. 29G-J illustrate a method for using a retraction lock 2920. FIG.29G is a transverse cross-section of the tissue localization devicehandle 902 including the retraction lock 2920, and FIG. 29H is a sideview of the tissue localization device 900 including the retraction lock2920. The retraction lock 2920 can be a structure external to the handle902 and coupled to the handle 902 or the slidable delivery control 904.The retraction lock 2920 can be fabricated from metal (e.g., as awireform) or fabricated as a polymer (e.g., via molding). The retractionlock 2920 can have one or more arms 2922 configured to lock a positionof the slidable delivery control 904 when or after the localizationelement 930 has been deployed into tissue. The retraction lock 2920 canbe rotatably coupled to the slidable delivery control 904 and/or thearms 2922 can be elastically deformable from a biased unlockedconfiguration shown in FIGS. 29G and 29H to a relaxed or unbiased lockedconfiguration shown in FIGS. 29I and 29J. The arms 2922 can elasticallypop and/or rotate into a locked configuration, as shown by arrows 2925.The arms 2922 can slide along an exterior of the handle 902 duringlongitudinal motion of the slidable delivery control 902, and rotate tolock into the handle 902 or pusher plug 926 through holes 2924 in thehandle 902. FIG. 29I is a transverse cross-section illustrating the arms2922 that can be locked into the holes 2924 to lock motion of theslidable delivery control 904, while FIG. 29J is a side view of thetissue localization device 900 with the arms 2922 that can be lockedinto the holes 2924. The retraction lock 2920 can be spring loaded suchthat the arms 2922 can automatically pop into the holes 2924, or theretraction lock 2920 can be configured to be manually clamped into theholes 2924 by a user of the device 900.

As described above, the tissue localization device 900 can be used withan ultrasound transducer. The user can operate the tissue localizationdevice 900 with one hand and the ultrasound transducer with the otherhand, using the ultrasound transducer to monitor deployment of thelocalization element 930 into tissue.

A user may use x-ray to confirm the desired deployment of thelocalization element 930. An example use of the tissue localizationdevice 900 under x-ray monitoring is shown in FIGS. 30A-B. FIG. 30Aillustrates a top view of a mammographic x-ray setup, which include abucky 3010 and a support platform 3020. FIG. 30B illustrates a side viewof the setup shown in FIG. 30A.

Referring to FIGS. 30A-B, the bucky 3010 can support tissue 2300 forx-ray imaging. The bucky 3010 can be placed on an opposite side of thetissue 2300 from an x-ray tube delivering x-rays to the tissue 2300. Forexample, in FIG. 30A, the bucky 3010 is below the tissue 2300, which canbe placed below an x-ray tube (not shown). The bucky 3010 mayalternatively be aligned in a vertical direction, such that the tissue2300 is placed horizontally between an x-ray tube and the bucky 3010 forimaging.

The support platform 3020 can couple to the bucky 3010 and support thetissue localization device 900. The support platform 3020 can clamp tothe bucky 3010, adhere to an adhesive on the bucky 3010, lock intobrackets in the bucky 3010, or otherwise removably couple to the bucky3010. Alternatively, the support platform 3020 can be integrated withthe bucky 3010. In some variations, the support platform 3020 may beadjustable to accommodate different tissue sizes or different angles ofentry into the tissue. For example, the support platform 3020 may behinged to tilt the tissue localization device 900 at an angle from ahorizontal plane of the bucky 3010 or to swivel within the horizontalplane. The support platform 3020 may additionally or alternatively havean adjustable height to adjust a distance between the needle of thetissue localization device 900 and the bucky 3010. The platform 3020 mayfurther include supports to maintain a position of the tissuelocalization device 900. For example, the platform 3020 may includestraps to strap the tissue localization device 900 to the platform 3020or protruding structures placed at sides and ends of the tissuelocalization device 900 to reduce a likelihood of the device 900 rollingor sliding on the platform 3020.

As shown in FIGS. 30A-B, a user (e.g., a radiologist) may guide apatient until the patient is positioned with tissue of interest 2300placed between the bucky 3010 and an x-ray tube. After initial x-rayimaging of the tissue 2300 to identify a target tissue site in thetissue 2300, the user may guide the needle of the tissue localizationdevice 900 into the tissue 2300 and deploy the localization element 930into the tissue. To ensure correct positioning of the localizationelement 930 in the tissue, the user may repeat x-ray imaging of thetissue 2300 before, during, or after deployment of the localizationelement 930. The user may leave the patient's side during imaging toreduce the user's exposure to the x-rays. The support platform 3020 cantherefore support the tissue localization device 900 in the user'sabsence, maintaining the positioning of the device and localizationelement 930 during imaging and improving comfort for the patient. Afterthe localization element 930 has been deployed to the user'ssatisfaction, the user can withdraw the tissue localization device 900from the tissue 2300 and expose the tracking wire 932, as describedabove.

FIGS. 31A-B illustrate that a tissue localization wire 3100 can be usedto localize tissue without (as shown) or with the localization element930 and tracking wire 932. The tissue localization wire 3100 can bedeployed from a handle/pusher/slidable delivery control based needlesystem similar to that described by the tissue localization device 100or 900, or can be configured to be advanced manually directly through adelivery needle (e.g., without use of the pusher element 920 and/orslidable delivery control 904).

The tissue localization wire 3100 can include a localization element3130 and a tracking wire 3132. The localization element 3130 can be aflexible wire or length of metal, polymer, or combinations thereof. Thelocalization element 3130 can be configured to take on an arcuate orcurvilinear configuration when deployed into tissue, an example of whichis shown in FIG. 31A. Alternatively, the localization element 3130 canbe configured to take on a linear or bent configuration when deployed,as shown for example in FIG. 31B. The localization element 3130 canalternatively take on different shapes. The localization element 3130 isstiff enough to pierce into tissue of a patient and maintain a relativeposition in the tissue as the patient moves, but flexible enough tocollapse, prior to deployment, into a delivery needle (e.g., thedelivery needle 906 of the tissue localization device 900).

The highly flexible suture-like tracking wire 3132 can be coupled to thelocalization element 3130 and configured to aid deployment of thetracking wire 3132 from a delivery needle. For example, if the tissuelocalization wire 3100 is configured for manual deployment from adelivery needle, the tracking wire 3132 can be configured to push thelocalization element 3130 out of the delivery needle when the trackingwire 3132 is pushed. After the localization element 3130 has beendeployed into tissue of a patient, at least a portion of the trackingwire 3132 may extend from the tissue to serve as a path or trail guidinga surgeon to the target tissue site. The exposed portion of the trackingwire 3132 is flexible enough to be able to be configured to be wrappedor tied and secured to the surface of the skin by, for example, adhesivedressing. For example, the exposed portion of the tracking wire 3132 maybe wrapped into a circle approximately 1-5 cm in diameter and taped bysurgical tape to the patient.

The tracking wire 3132 can be a flexible wire including one or moremulti-strand filaments encased in a polymer jacketing, such as thepolymer jacketing 1132. However, the tracking wire 3132 canalternatively include any metal, metal alloy, polymer, or combinationsthereof, and can be a single-stranded wire, a multi-stranded wire, acoil spring similar to flexible guidewires used in cardiovascularapplications, encased in a jacketing, or not encased in a jacketing, orpolymer (e.g. fluoropolymer) coated. The tracking wire 3132 can have asubstantially circular cross-section, or can have cross-sections ofother shapes (e.g., square). The tracking wire 3132 can have sufficientcolumn strength to facilitate deployment (e.g., by pushing) of thelocalization element 3130 out the end of a delivery needle, but possesssufficient flexibility to be easily coiled without yielding so that itmay be comfortably secured to tissue surface of a patient. The trackingwire 3132 may be between approximately 0.010 and 0.025 inches indiameter. When the tracking wire 3132 is configured to be pushed by handthrough a delivery needle, the tracking wire 3132 may have asufficiently large diameter and/or be sufficiently column strength toprevent buckling or “S”ing within the needle lumen. The tracking wiremay be longer or shorter than shown in FIGS. 31A-B.

It can be difficult to perform wire localization procedures or otherultrasound guided breast procedures because the tissue is particularlymobile or unstable, as in the instance of a fatty-replaced breast. Theinstability and mobility of the fatty tissue can make it challenging foreven a skilled clinician to place an ultrasound-guided needle to thedesired location. The mere act of mildly pressing an ultrasound on theskin near the target tissue can cause the target tissue to move out ofthe field of view of the ultrasound transducer. The forces involved inplacing and advancing a needle through this tissue can cause additionalunwanted mobility of the tissue, further compromising ultrasoundvisualization.

FIG. 32A illustrates a tissue stabilization device, such as a securementor stabilization sling 3200 for stabilizing tissue to be penetrated bythe tissue localization device 900 or 100 and imaged by an ultrasoundprobe. The sling 3200 can stabilize breast tissue and provide supportfor such tissue as the delivery needle 906 of the tissue localizationdevice 900 or 100 or other ultrasound-guided devices (e.g., percutaneousbiopsy, fine needle aspiration, and percutaneous marker devices) Thesling 3200 can stabilize the mobile tissue and allow for needlepenetration as well as positioning of the ultrasound probe for realtimeultrasound guidance

The sling 3200 can comprise a polymeric material, a fabric, orcombinations thereof. The sling 3200 can comprise aniodophor-impregnated layer or coating (e.g., 3M™ Ioban™ incise drapes orcoverings), for example to cover the skin and minimize the risk ofsurgical site infection. The sling 3200 can comprise an anti-microbiallayer that does not contain iodine, for example, for patients who havean iodine allergy. The anti-microbial layer can comprise silvernanoparticles. The sling 3200 (or other stabilization devices hereindescribed) can be used to support mobile tissue such as, but not limitedto, breast tissue (as stated above), abdominal tissue, leg tissue, upperarm tissue, buttock tissue, or scrotal tissue. The sling 3200 cancomprise one or more biocompatible adhesive-backed layers that adhere tothe skin to provide an appropriate ultrasound interface and a grip onthe skin to maintain traction on the tissue to decrease tissue mobility.

The sling 3200 can deliver a support pressure 3202 against the breastsurface. The support pressure 3200 can have a directional componenttoward the medial direction of the wearer of the sling. The tissuelocalization device 900 or 100 can be inserted, as shown by arrow 3204,into the breast not through and medial to the sling (as shown) orthrough the sling. The insertion direction of the tissue localizationdevice can have a directional component toward the lateral side of thewearer of the sling. The support pressure 3200 can prevent or minimizebreast motion or deformation during the insertion and other use of thetissue localization device 900 or 100 in the breast.

FIG. 32B illustrates that a patch 3206 can be placed on the breast, forexample at the site of insertion of the tissue localization device 900or 100 through the skin. The patch 3206 can be placed on the breastbefore insertion of the tissue localization device 3200 through thepatch 3206 and the breast skin. The patch 3206 can be above or below thesling 3200. The patch 3206 can be attached to the sling 3200. The patch3206 can be made from the same or different material as the sling 3200.The patch 3206 can have one or more iodophor-impregnated layers orcoating (e.g., 3M™ Ioban™ incise drapes or coverings), for example tocover the skin and minimize the risk of surgical site infection.

The tissue stabilization devices can be comprised of a clamshell typedevice, with one side of the clamshell having a rigid surface and theother side of the clamshell comprised of a yoke (e.g. two prongs) thatsuspend a segment of flexible adhesive polymer sheeting such as Ioban™between the two prongs. The hinge of the clamshell may be spring loadedto “close” the clamshell and/or may have a releaseable ratchetingmechanism to hold the clamshell closed around the breast tissue at anadjustable (e.g., by further ratcheting or release of the ratchet) levelof compression. The clamshell can be closed around the breast. Theinterior surface of the rigid side of the clamshell can contact thepatient's breast and form a stable platform against which the breast canbe further stabilized by the opposing side of the clamshell. Theopposing surface of the clamshell may be comprised of an adhesive-backedpolymer sheeting whose inner surface is pressed against the breast sothat the breast tissue can be mildly compressed between the clamshelldevice. The clamshell can be applied to the breast in a number ofdirections (e.g. cranio-caudal, medial-lateral, etc.) as desired by theclinician. The rigid clamshell can be configured to have a pad (e.g.foam) to aid in comfort during compression. After the clamshell has beenapplied to the breast, an ultrasound probe and needle may be placed intoor onto either the exposed skin or the adhesive film region of thestabilization device.

The two opposing sides can be not hinged as in the clamshellconfiguration described above. For example, the two roughly parallelsurfaces can be advanced towards each via one or more ratchet orscrew-feed mechanisms until the desired level of compression around thebreast is achieved. As with the previously described clamshell device,one compression surface can be relatively rigid while the opposingcompression surface can be comprised of flexible film suspended by theprongs of a yoke. The rigid side need not be a flat plane but can alsobe curved (e.g. slightly concave) to provide additional comfort andstabilization. In use, the two opposing sides can be brought togetheraround the breast in the desired orientation and the breast tissue isthus stabilized for use in an ultrasound guided percutaneous procedure.At the end of the procedure the stabilization device can be released andthe film removed.

The film region need not comprise the entire compression surface. Bothsides can be rigid and there can be window regions within thecompression surfaces. The window regions may or may not contain filmsheeting depending on the size of the window. In some instances windowsin the compression surfaces will not be needed (e.g., in some largebreasted patients) and the skin can be sufficiently accessed in areaswhere there are not compression surfaces. Both compression sides can becomprised of the film yoke to optimize accessibility of the breast tothe needle or ultrasound probe.

Each of the individual variations described and illustrated herein hasdiscrete components and features which may be readily separated from orcombined with the features of any of the other variations. Modificationsmay be made to adapt a particular situation, material, composition ofmatter, process, process act(s) or step(s) to the objective(s), spiritor scope of the disclosure.

Methods recited herein may be carried out in any order of the recitedevents that is logically possible, as well as the recited order ofevents. Moreover, additional elements of the method or operations may beprovided or elements of the method or operations may be eliminated toachieve the desired result.

Furthermore, where a range of values is provided, every interveningvalue between the upper and lower limit of that range and any otherstated or intervening value in that stated range is encompassed withinthe disclosure. Also, any optional feature of the inventive variationsdescribed may be set forth and claimed independently, or in combinationwith any one or more of the features described herein.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications and hardware) is incorporated by referenceherein in its entirety except insofar as the subject matter may conflictwith that of the present disclosure (in which case what is presentherein shall prevail). The referenced items are provided solely fortheir disclosure prior to the filing date of the present application.Nothing herein is to be construed as an admission that the disclosure isnot entitled to antedate such material by virtue of prior disclosure.

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. Unless defined otherwise, alltechnical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisdisclosure belongs.

This disclosure is not intended to be limited to the scope of theparticular forms set forth, but is intended to cover alternatives,modifications, and equivalents of the variations or variations describedherein. Further, the scope of the disclosure fully encompasses othervariations that may become obvious to those skilled in the art in viewof this disclosure.

We claim:
 1. A tissue localization device, comprising: a delivery needlecomprising a needle lumen; a localization element slidably translatablewithin the needle lumen, wherein the localization element is detachablefrom the delivery needle; and a liner in the needle lumen, wherein theliner is slidably translatable relative to the needle lumen and isradially between the needle lumen and at least part of the localizationelement.
 2. The device of claim 1, further comprising: a handlecomprising a slidable delivery control, wherein the delivery needleextends from the handle; a pusher element partially within the needlelumen, wherein the localization element is detachably held by the pusherelement and wherein the localization element is detachable from thepusher element in response to a translation of the slidable deliverycontrol in a first longitudinal direction.
 3. The device of claim 2,wherein the localization element is releasable from the liner when adistal end of the pusher element is translated longitudinally beyond theliner.
 4. The device of claim 2, wherein the slidable delivery controlcomprises a first interface surface and a second interface surface,wherein the handle comprises a proximal end and a distal end, andwherein the first interface surface is upwardly concave when viewed fromthe proximal end to the distal end and the second interface surface isupwardly concave when viewed from the distal end to the proximal end. 5.The device of claim 2, wherein the handle comprises a handle dorsalside, a handle ventral side opposite the handle dorsal side, and whereinthe localization element is configured to curve in a direction of thehandle dorsal side when deployed.
 6. The device of claim 5, wherein thehandle has an elongate slot along the handle dorsal side, wherein theslidable delivery control is coupled to the pusher element via afastener extending through the elongate slot.
 7. The device of claim 2,wherein the pusher element comprises a delivery port at a distal end ofthe pusher element and wherein at least part of the localization elementis detachably held within the delivery port when the localizationelement is within the needle lumen.
 8. The device of claim 2, whereinthe pusher element has a pusher dorsal side, a pusher ventral side, anda pusher distal end, wherein the pusher distal end is sloped and formsan obtuse angle with the pusher ventral side.
 9. The device of claim 2,further comprising a spring coupled to a proximal end of the liner,wherein the spring is configured to be at least partially compressedwhen the pusher element is translated toward a distal end of thedelivery needle relative to the liner in response to a translation ofthe slidable delivery control in the first longitudinal direction. 10.The device of claim 1, wherein the localization element comprises anechogenic surface treatment.
 11. The device of claim 1, furthercomprising a tracking wire coupled to the localization element, whereinat least a segment of the tracking wire is configured to be coiled ortied into a loop.
 12. A tissue localization device, comprising: adelivery needle comprising a needle lumen; a pusher element slidablytranslatable within the needle lumen, wherein the pusher elementcomprises a delivery port; and a localization element comprising aninterlocking framework, wherein the interlocking framework isinterlockable with the delivery port when at least part of the pusherelement resides within the needle lumen, and wherein the interlockingframework is releasable from the delivery port when the delivery portexits the needle lumen.
 13. The device of claim 12, further comprising ahandle comprising a delivery control, wherein the delivery needleextends out from the handle and wherein the delivery control is coupledto the pusher element.
 14. The device of claim 12, wherein theinterlocking framework of the localization element comprises an eyeletframe and a shoulder portion, and wherein the eyelet frame is detachablypositioned within the delivery port when the localization element iswithin the needle lumen.
 15. The device of claim 12, further comprisinga tracking wire coupled to the localization element, wherein at least asegment of the tracking wire is configured to be coiled or tied into aloop.
 16. A method for using a tissue localization device, comprising:translating a localization element of the tissue localization device ina first longitudinal direction through a needle lumen of a deliveryneedle of the tissue localization device; deploying a localizationelement of the tissue localization device out of the delivery needleinto tissue; retracting the localization element into the needle lumenafter at least part of the localization element is deployed out of thedelivery needle; repositioning the tip of the delivery needle; andredeploying the localization element out of the delivery needle into thetissue.
 17. The method of claim 16, further comprising deploying thelocalization element out of the delivery needle into a curvedconfiguration having a first curvature plane and redeploying thelocalization element out of the delivery needle into the curvedconfiguration having a second curvature plane.
 18. The method of claim16, further comprising: positioning an ultrasound transducer on thetissue; and moving the ultrasound transducer on the tissue whiletranslating the localization element.
 19. The method of claim 16,further comprising: advancing a needle tip of the delivery needle intothe tissue to an offset from a target tissue site of the tissue; anddeploying the localization element out of the delivery needle by pushinga slidable delivery control of the tissue localization device in thefirst longitudinal direction along a handle of the tissue localizationdevice.
 20. The method of claim 19, further comprising compressing aspring coupled to a proximal end of a liner partially encasing a pusherelement coupled to the slidable delivery control prior to deploying thelocalization element out of the delivery needle.